FOI release
Yellow Card ADR data
Case reference FOI2026/00099
Received 30 January 2026
Published 9 March 2026
Request
Thank you for your response to my previous request (FOI2026/00004). In line with your Section 16 advice, I am submitting a narrowed and specific revised request, designed to fall within the statutory cost limit. This revised request is limited to structured adverse-event data only, and excludes internal correspondence, policy development, or narrative analysis. Scope limitations (important) • Time period: 2015–2025 only • Data source: Yellow Card adverse incident reports only • Device focus: Modular hip taper junctions involving: o a stainless steel femoral stem, and o a titanium modular neck sleeve (including BioBall-type systems) • Failure mode: Mechanical or material degradation at the taper interface only ________________________________________ Requested Information 1. Yellow Card reports – taper interface degradation For the period 2015–2025, please provide the number of Yellow Card reports recorded by the MHRA that reference any of the following at a modular hip taper junction involving stainless steel and/or titanium components: • fretting • corrosion • material fragmentation • particulate debris • taper junction failure A year-by-year total is sufficient. ________________________________________ 2. Revision surgery linkage Of the reports identified above, please confirm how many explicitly recorded that revision surgery was required. (A numerical count only; no case narratives required.) ________________________________________ 3. Systemic or local tissue effects (coded fields only) Please confirm, where recorded in structured fields, how many of the reports in Question 1 were associated with: • adverse local tissue reaction (ALTR / metallosis / pseudotumour), and/or • elevated blood metal ion levels Again, aggregate counts only. ________________________________________ 4. Device material classification Please confirm whether, within Yellow Card reporting categories used by the MHRA: • stainless steel femoral stems and • titanium modular neck sleeves are recorded as distinct material classifications, or whether they are grouped under a broader “metal” category for adverse-event coding purposes. ________________________________________ Exclusions (to confirm) For clarity, this request does not seek: • internal MHRA emails or briefing papers • unpublished safety notices • policy deliberations or expert panel discussions • trend analysis or interpretive commentary ________________________________________ If any part of this revised request still risks exceeding the cost limit, I would be grateful if you could indicate which specific question(s) present difficulty, so I may refine further.
Response
See attached
Documents
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