OXINIUM 71343204Recalls & reported problems
Smith & Nephew, Inc. · OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +4 · Class 2 · Implant
All models of OXINIUM (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Oxinium femoral head is the ball component used in hip replacement surgery. The 38 reports mostly describe the hip implant dislocating or slipping out after surgery, sometimes with pain or infection, leading to revision surgery in which the head was replaced. No deaths were reported and 35 injuries were. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 03596010474223), received between Apr 14, 2018 and Mar 9, 2026 — classified as 35 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 reports).
4 other recalls cover devices cleared under the same FDA submission (K021673, K024340, K030766, K211176); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem16
- Device Dislodged or Dislocated10
- Insufficient Device Problem Information5
- Unintended Movement2
- Biocompatibility1
- Delivered as Unsterile Product1
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Dislocation15
- Unspecified Infection8
- Injury3
- No Clinical Signs, Symptoms or Conditions3
- Failure of Implant2
- No Information2
- No Known Impact Or Consequence To Patient2
- Arthralgia1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A THA THAT TOOK PLACE ON 2007, A REVISION SURGERY TOOK PLACE ON (B)(6) 2026 DUE TO THE DISLOCATION OF THE IMPLANT. THE RF INTERFIT ACET TH SZ 56, REF XLPE 32 20 DEG 54-56 F AND OXINIUM FEM HD 12/14 32MM +4 WERE EXCHANGED. NO MORE DETAILS AVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 24544050 ↗InjuryOct 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
: IT WAS REPORTED THAT ON (B)(6) 2020, A PRIMARY TOTAL HIP ARTHROPLASTY WAS PERFORMED USING SMITH & NEPHEW COMPONENTS, INCLUDING AN R3 ACETABULAR SHELL ¿ 0 HOLE, HA COATED, 52MM (REF. 71332252, LOT 19KM05890), A THREADED HOLE COVER (REF. 71330001, LOT 20AM23709), AN R3 ACETABULAR LINER ¿ 0° XLPE, 32MM X 52MM (REF. 71339552, LOT 19GM06421), AN ANTHOLOGY FEMORAL STEM ¿ SIZE 9, SO POROUS PLASMA HA (REF. 71357009, LOT 14BM12043), AND AN OXINIUM FEMORAL HEAD ¿ 12/14 TAPER, 32MM, +4MM OFFSET (REF. 71343204, LOT 20BM09596). THE PATIENT HAD SUSTAINED A FALL APPROXIMATELY THREE YEARS PRIOR, RESULTING IN SOFT TISSUE DAMAGE AND PERSISTENT JOINT LAXITY, WHICH PREDISPOSED THE HIP TO INSTABILITY. DESPITE THE INITIAL PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE DISLOCATIONS OVER THE FOLLOWING YEARS AND WAS REPORTEDLY NON-COMPLIANT WITH POST-OPERATIVE PHYSIOTHERAPY INSTRUCTIONS REGARDING LEG MOVEMENTS, CONTRIBUTING TO ONGOING INSTABILITY. DUE TO RECURRENT DISLOCATIONS UNRESPONSIVE TO CONSERVATIVE MANAGEMENT, A FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE R3 ACETABULAR LINER ¿ 0° XLPE, 32MM X 52MM (REF. 71339552, LOT 19GM06421) AND OXINIUM FEMORAL HEAD ¿ 12/14 TAPER, 28MM, +
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 23251664 ↗InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED DISLOCATION WHEN GETTING UP. ACCORDING TO THE DOCTOR, THE REASON FOR THE DISLOCATION WAS UNKNOWN. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE OXINIUM FEM HD 12/14 32MM +4 AND THE R3 0 DEGREE XLPE LNR 32MM X 54MM WERE EXCHANGED TO AN OXINIUM FEM HD 36MM +12 AND TO A NEW R3 0 DEGREE XLPE LNR 32MM X 54MM, RESPECTIVELY. THE CUP AND THE STEM REMAINED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 20684266 ↗MalfunctionApr 25, 2024Wrong Label; Wrong Label
IT WAS REPORTED THAT, DURING A THR SURGERY, UPON OPENING THE BOX LABELED FOR ONE (1) OXINIUM FEM HD 12/14 32MM +4, IT WAS NOTICED THAT IT CONTAINED AN OXINIUM FEM HD 12/14 36MM +4 INSTEAD. BOTH THE PACKAGING AND THE STICKERS INSIDE INDICATED THAT THE IMPLANT WAS AN OXINIUM FEM HD 12/14 32MM +4. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19187783 ↗InjuryAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN AND DISLOCATION. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023 TO TREAT THIS ADVERSE EVENT IN WHICH A OXINIUM FEM HD 12/14 32MM +4 WAS EXCHANGED WHILE A R3 20 DEG +4 XLPE ACET LNR 32MM X 50MM REMAINED. IN ADDITION, THE SURGEON DOES NOT BELIEVE THAT THE PRODUCT IS AT FAULT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Arthralgia; Joint Dislocation
MAUDE report 17466809 ↗InjuryFeb 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL HEAD AND LINER WERE EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Subluxation
MAUDE report 16291464 ↗InjuryJan 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY DOING A REVISION SURGERY ON (B)(6) 2022, IN WHICH ALL COMPONENTS WERE REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 16134747 ↗InjuryDec 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH SMITH AND NEPHEW COMPONENTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 16047696 ↗InjuryDec 19, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED A DISLOCATION DUE TO LOOSENING OF THE IMPLANT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 WERE AN OXINIUM FEM HD 12/14 32MM +4 AND A R3 20 DEG XLPE ACET LNR 32MM X 50MM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Inadequate Osseointegration; Joint Dislocation
MAUDE report 16009611 ↗InjuryNov 15, 2022Biocompatibility; Biocompatibility
IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS THAT MADE NECESSARY A REVISION SURGERY ON 3-NOV-15. DURING THIS PROCEDURE, THE FEMORAL STEM, THE LINER AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH SMITH AND NEPHEW COMPONENTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Foreign Body Reaction
MAUDE report 15801092 ↗InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2016 TO ADDRESS TRAUMA - CHRONIC SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE, THE FEMORAL HEAD, ACETABULAR CUP AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH SIMILAR DEVICES. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS.
Patient problems: Joint Dislocation
MAUDE report 15735583 ↗InjuryNov 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2016 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A NEW SMITH AND NEPHEW OXINIUM FEMORAL HEAD. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 15721550 ↗InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT REQUIRED REVISION SURGERY TO EXPLANT THE OXONIUM FEM HD 12/14 32 MM +4 BECAUSE OF AN INFECTION. DURING THIS PROCEDURE, A WASHOUT WAS ALSO PERFORMED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 14713794 ↗InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2022 TO WASHOUT THE HIP AND EXCHANGE THE R3 0 DEG XLPE ACET LNR 32MM X 50MM AND OXINIUM FEM HD 12/14 32MM +4. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 14502239 ↗InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN EARLY DISLOCATION. A REVISION SURGERY WAS REQUIRED TO ADDRESS THIS EVENT; THE R3 0 DEG XLPE ACET LNR 32 MM X 56 MM AND THE OXONIUM FEM HD 12/14 32 MM +4 WERE EXPLANTED. THE LINER WAS CHANGED TO A CONSTRAINED LINER. ACETABULAR CUP AND FEMORAL STEM WERE LEFT IN SITU. CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 12497274 ↗InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Scratched Material; Adverse Event Without Identified Device or Use Problem; Scratched Material
IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED RECURRENT JOINT DISLOCATIONS. THE DISLOCATIONS WERE CAUSED BY THE OXINIUM FEM HD 12/14 32MM +4 DISLOCATING FROM THE R3 0 DEG XLPE ACET LNR 32MM X 50MM. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021, IN WHICH IT WAS CONFIRMED THAT THE R3 3 HOLE HA CTD ACET SHELL 50MM WAS WELL FIXED AND A SEVERE SCRATCH WAS NOTICED ON THE OXINIUM FEM HD 12/14 32MM +4. THE R3 0 DEG XLPE ACET LNR 32MM X 50MM AND OXINIUM FEM HD 12/14 32MM +4 WERE REPLACED, AND AS A CONSEQUENCE OF THAT REPLACEMENT, THE R3 3 HOLE HA CTD ACET SHELL 50MM HAD TO BE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 12311026 ↗InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER THA HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED A BONE FRACTURE WITH MALALIGNMENT OF THE STEM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 WHERE POLARSTEM STEM STD TI/HA 01 NON-CEM AND OXINIUM FEM HD 12/14 32MM +4 WERE EXPLANTED. PATIENTS CURRENT HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY FOR (B)(6) AND (B)(6) SUPPLIER FEEDBACK; THEREFORE, FURTHER INFORMATION IS NOT AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 12242530 ↗InjuryJun 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2020, A FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO DISLOCATION ((B)(4)). A SECOND HIP REVISION WAS PERFORMED ON (B)(6) 2021 TO REMOVE LINER AND FEMORAL HEAD AS THE PATIENT CONTINUOUSLY DISLOCATED. A NEW FEMORAL HEAD AND +4 LINER WAS IMPLANTED WITH SUCCESS. PATIENT WAS NOT HARMED.
Patient problems: Joint Dislocation
MAUDE report 12086262 ↗MalfunctionJun 12, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT, AN OXINIUM FEM HD 12/14 32MM +4 WAS DELIVERED IN AN UNSTERILE STATE. AS THIS WAS NOTICED DURING INSPECTION ACTIVITIES, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11988789 ↗InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A PRIMARY THR ON (B)(6) 2020 AND SHOWED SIGNS OF INFECTION AND THIS WAS CONFIRMED BY PATHOLOGY. REVISION SURGERY PERFORMED USING CPCS AND ALL POLY REFLECTION CUP WITH COPAL ANTIBIOTIC CEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 11350031 ↗InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2021 TO INSTALL A CONSTRAINED LINER BECAUSE OF RECURRING DISLOCATION. THE PATIENT ADMITTED TO BEING NON COMPLIANT. PRIMARY SURGERY WAS PERFORMED ON AUGUST, (B)(6) 2020. ACETABULAR LINER AND FEMORAL HEAD WERE THE DEVICES EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11283684 ↗InjuryJan 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED, THERE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO REMOVE THE FEMORAL HEAD. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 11144654 ↗InjuryDec 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, THE PATIENT HAS A SPECTRON R3 HIP INSITU AND HAD A HIP REVISION SURGERY DUE TO A DISLOCATION. A NEW OXINIUM FEM HD 12/14 32MM +4 WAS IMPLANTED WITH SUCCESS. PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 11038586 ↗InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKR HAD BEEN PERFORMED, THE PATIENT HAD AN INTRA-ARTICULAR INFECTION. A REVISION SURGERY WAS PERFORM TO TREAT THIS ADVERSE EVENT. THE OXINIUM FEMORAL HEAD WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 10054643 ↗InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY AND A WASHOUT WERE PERFORMED DUE TO INFECTION. THE LINER AND HEAD WERE REPLACED. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020.
Patient problems: Unspecified Infection
MAUDE report 10003205 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021673, K024340, K030766, K211176. One submission often covers many models, so check the product and lot details in each record.
- Z-0326-2025 · Oct 15, 2024 · Open, ClassifiedTandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
- Z-1901-2024 · Apr 24, 2024 · Open, Classifiedsmith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
- Z-0389-2010 · Jan 23, 2009 · TerminatedOxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
- Z-2314-2009 · Jan 12, 2009 · TerminatedTandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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