NA 71320028Recalls & reported problems
Smith & Nephew, Inc. · ZIRCONIA 12/14 TAPER FEMORAL HEAD 28MM + 0 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010196187), received between Apr 1, 2019 and Mar 5, 2021 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Unstable1
Patient problems
- Pain2
- Injury1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT, DUE TO A INFECTION, A POLY EXCHANGE WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 11419437 ↗InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT-SIDED THR HAD BEEN PERFORMED, THE PATIENT STARTED EXPERIENCING PAIN. AN X-RAY IMAGE SHOWED THAT THE LINER WAS WORN, SO THE SURGEON RECOMMENDED EXCHANGING THE LINER AND THE FEMORAL HEAD. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ISSUE: BOTH COMPONENTS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Pain
MAUDE report 10112952 ↗InjuryOct 29, 2019Unstable; Unstable
US LEGAL: IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATIONS AND INSTABILITY. LINER AND HEAD WERE REMOVED. THIS PATIENT UNDERWENT A CLOSED REDUCTION ON (B)(6) 2011 AND A DISLOCATION ON (B)(6) 2013. IN ADDITION TO THIS THE PATIENT HAD A FALL IN (B)(6) 2013 AND PRESENTED TROCHANTERIC BURSITIS DUE TO THIS INCIDENT.
Patient problems: Injury
MAUDE report 9253271 ↗InjuryApr 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. REMOVED FEMORAL HEAD AND LINER.
Patient problems: Pain
MAUDE report 8468305 ↗
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- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
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- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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