OXINIUM 71342340Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00885556112410), received between Feb 17, 2018 and Apr 15, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 reports).

1 other recall cover devices cleared under the same FDA submission (K093363, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Material Deformation

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE 40MM OXINIUM MODULAR HEAD (B)(4) AND THE R3 0 DEGREE XLPE ACET LNR 40MM ID X 60OD (B)(4) WERE SIGNIFICANTLY DAMAGED DUE TO THE CERAMIC PARTICLES THAT WERE STILL IN JOINT FROM A PREVIOUS CERAMIC LINER FRACTURE (UNKNOWN IF FROM S+N). THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE DEVICES WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24891030 ↗
• InjuryJun 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT HAS EXPERIENCED POSTERIOR DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 20 DEG XLPE LNR 40MM ID X 60 OD, ONE (1) TITANIUM MODULAR HEAD SLV 12/14 TPR -4, AND ONE (1) 40MM OXINIUM MODULAR HEAD WERE EXPLANTED AND REPLACED WITH AN ANTEVERTED LINER AND ANOTHER HEAD WITH INCREASED OFFSET TO GAIN HIP STABILITY AND STOP POSTERIOR DISLOCATION. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22235103 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF HER RIGHT THA SYSTEM (COMPETITOR PRODUCT) ON (B)(6) 2019 DUE TO PERIPROSTHETIC JOINT INFECTION AND LOOSENING. DURING THE REVISION SURGERY, THE FEMORAL COMPONENT AND THE BEARINGS WERE EXPLANTED AND REPLACED WITH A DEPUY LINER ACETABULAR, A SMITH AND NEPHEW REDAPT FEMORAL STEM, AND A SMITH AND NEPHEW OXINIUM FEMORAL HEAD. AS REPORTED, ON (B)(6) 2019, THE PATIENT SUFFERED FROM AN INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL RIGHT HIP PROSTHESIS AND WAS REVISED. DURING THIS SECOND REVISION SURGERY, THE FEMORAL HEAD, ACETABULAR INSERT AND LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20196465 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY THR PERFORMED ON (B)(6) 2023, THE PATIENT PRESENTED WITH A SUSPECTED INFECTION OF THE HIP REPLACEMENT. THEY REQUIRED TO COME BACK TO THEATRE FOR A WOUND AND JOINT WASH OUT AND HEAD EXCHANGE. PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Medical device site infection; Post Operative Wound Infection

  MAUDE report 18436496 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT THA, ONE (1) PATIENT EXPERIENCED UNSPECIFIED EVENTS THAT LED TO A SUBSEQUENT REVISION SURGERY COMBINED WITH INTERNAL FIXATION ON (B)(6) 2021, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. THE PATIENT SUFFERED AN INTRAOPERATIVE ACUTE PERIPROSTHETIC FRACTURE INVOLVING THE MEDIAL FEMORAL COMPONENT. THE FRACTURE FRAGMENT WAS DISPLACED MEDIALLY APPROXIMATELY 7 MM. ON THE LATERAL VIEW, IT WAS OBSERVED THAT THE FRACTURE MAY EXTEND TO THE GREATER TROCHANTERIC REGION. A POST-OPERATIVE FOLLOW-UP DETERMINED A WELL-HEALED WOUND WITH NO EVIDENCE OF SUBSIDENCE, LOOSENING, OR COMPLICATING FEATURES.

  Patient problems: Hip Fracture

  MAUDE report 16583207 ↗
• InjuryNov 1, 2022Degraded; Degraded

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2018, THE LINER WORE DOWN THE HEAD OF A 40MM OXINIUM MODULAR HEAD. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A 40MM OXINIUM MODULAR HEAD WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Unspecified Tissue Injury

  MAUDE report 15711858 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON 2013, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH 40 MM OXONIUM MODULAR HEAD AND R3 20 DEG +4 XLPE ACET LNR 40 MM X 58 OD WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. PREVIOUSLY, ON 2014, THE PATIENT HAD A REVISION SURGERY ALSO DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 12916319 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE CUP HAD LOOSENED AND SPUN, CAUSING A LEG LENGTH SHORTENING. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2021, IN WHICH THE ORGINAL CUP WAS EVALUATED AND DETERMINED TO BE WELL FIXED AFTER SCREW REMOVAL. HOWEVER, THE R3 0 DEG +4 XLPE ACET LNR 40MM ID X 56OD AND 40MM OXINIUM MODULAR HEAD WERE REPLACED, AND THE PLACEMENT OF THE NEW LINER AND HEAD ACCOUNTED FOR THE COMPLAINT OF LEG LENGTH DESCREPANCY, WHICH WAS EVALUATED THROUGH FULL ROM AND STABLE.

  Patient problems: Failure of Implant

  MAUDE report 12815454 ↗
• InjuryOct 29, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY WAS PERFORMED ON THE PLAINTIFF¿S RIGHT HIP ON (B)(6) 2017, THE PLAINTIFF EXPERIENCED INSTABILITY AND A JOINT DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE 40MM OXINIUM MODULAR HEAD WAS EXPLANTED. A BLACKENED TISSUE WAS NOTICEABLE INTRAOPERATIVELY DUE TO A SIGNIFICANT WEAR PRESENT ON THIS EXPLANTED HEAD. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 12720454 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A 2ND STAGE REVISION ON (B)(6) 2020 DUE TO A LEFT THR INFECTION, PATIENT HAD ANOTHER INFECTION IN THE SAME HIP THEREFORE HAD A FIRST STAGE REVISION LEFT THR ON (B)(6) 2021. IT WAS INDICATED BY A DISEASES SPECIALIST A REVISION SURGERY TO REMOVE ALL PROSTHESIS AS THE ORGANISM CAUSING THE INFECTION IS SUSCEPTIBLE TO ANTIBIOTIC THAT THE PATIENT IS ALLERGIC. ALL PROSTHESIS WERE REMOVED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 11284767 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A REVISION HIP, REMOVING A BHR CUP AND EMPERION STEM WITH BHR MODULAR HEAD. HE REPLACED THIS WITH A 76MM R3 MULTIHOLE SHELL, A 40MM ZERO DEGREES LINER AND A 23MM X 240MM SLEEVELESS REDAPT STEM. DURING THE TRIALING STAGE, IT WAS FOUND THAT THE SHOULDER OF THE STEM IMPINGED ON THE RIM OF THE CUP AT AROUND THE 10 O'CLOCK POSITIONS DURING ABDUCTION AND EXTERNAL ROTATION OF THE LIMB. HE TRIED VARIOUS COMBINATIONS OF HEAD LENGTHS, OFFSET LINER, AND NECK OPTIONS. HE FEELS THE CUP VERSION IS NORMAL AND THE SHOULDER OF THE STEM SHOULD NOT IMPINGE AT THIS POINT. NO MORE INFORMATION WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9328345 ↗
• InjuryOct 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED RECURRENT LEFT HIP DISLOCATION AND GREATER TROCHANTER FRACTURE ON (B)(6) 2018 AND (B)(6) 2018. OPEN REDUCTION PERFORMED TO CORRECT THE PROBLEM.

  Patient problems: Injury

  MAUDE report 9171678 ↗
• InjuryMay 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT RIGHT HIP DISLOCATION HAS OCCURRED. HIP REDUCTION PERFORMED.

  Patient problems: Injury

  MAUDE report 8643155 ↗
• InjuryMay 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LEFT HIP DISLOCATION HAS OCCURRED. PATIENT REQUIRED CLOSED REDUCTION TO AMEND.

  Patient problems: Injury

  MAUDE report 8643154 ↗
• InjuryMay 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8643150 ↗
• InjuryMay 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED POSSIBILITY FOR THE UNDERLYING HEMATOMA TO HAVE BECOME INFECTED FROM THE CELLULITIS, SUGGESTING THE DEVICE IS LIKELY TO BE INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 8643148 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD RECURRENT RIGHT HIP DISLOCATIONS ON (B)(6) 2018 AND (B)(6) 2018.

  Patient problems: Joint Dislocation

  MAUDE report 8636120 ↗
• InjuryMar 22, 2019Unstable; Unstable

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LEFT ANTERIOR HIP DISLOCATION WITH RECURRENT INSTABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 8446379 ↗
• InjuryMar 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE RIGHT HIP SINCE, UPON CT SCAN, IT WAS NOTICED THAT ONE OF THE PELVIC SCREWS WAS IN THE SOFT TISSUES REQUIRING FEMORAL HEAD REVISION.

  Patient problems: Injury

  MAUDE report 8418544 ↗
• InjuryMar 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY ON THE RIGHT HIP DUE TO POSSIBLE INFECTION; IRRIGATION AND DEBRIDEMENT WERE PERFORMED ALONG WITH HEAD EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 8416870 ↗
• InjuryJan 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT ON (B)(6) 2013 DUE TO IMPLANT FAILURE. FEMORAL HEAD WAS EXPLANTED. NO COMPLICATIONS REPORTED. RELATED TO EVENTS IN MDR 3005975929-2018-00219 AND MDR 3005975929-2018-00267.

  Patient problems: Injury

  MAUDE report 8295178 ↗
• InjuryJan 14, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE REP INADVERTENTLY RETRIEVED THE 40MM FEMORAL HEAD AND FROM STOCK AND CHECKED THE IMPLANT OFF WITH TWO MEMBERS OF THE OPERATING ROOM (OR) STAFF. THE REP THEN HANDED THE IMPLANT TO THE CIRCULATING NURSE. THE NURSE THEN OPENED THE IMPLANT TO THE STERILE FIELD, AND THE 40 MM HEAD WAS IMPLANTED. A 44 INNER DIAMETER LINER WAS ALREADY IMPLANTED, SO THERE WAS A DISCREPANCY IN HEAD AND LINER SIZE. THE ERROR WAS NOTICED THE FOLLOWING DAY, AND THE SURGEON WAS IMMEDIATELY NOTIFIED. A REVISION SURGERY WAS THEN PERFORMED ON (B)(6) 2018 WITH NO ADDITIONAL ISSUES.

  Patient problems: Injury

  MAUDE report 8245387 ↗
• InjuryJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND DUE TO A DISLOCATION IN (B)(6), AN OPEN REDUCTION WAS PERFORMED.

  Patient problems: Joint Dislocation

  MAUDE report 8226129 ↗
• InjuryJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8226078 ↗
• InjuryJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY THR IN (B)(6) 2018 AND PATIENT HAD A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8226030 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093363, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem 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.