NA 71303600Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010479983), received between Feb 24, 2019 and Jul 25, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K022902, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, ONE DAY AFTER A THR SURGERY, THE PATIENT PRESENTED WITH A HIP DISLOCATION ONE DAY POST IMPLANTATION, THEREFORE A REVISION SURGERY HAD TO BE PERFORMED TO EXCHANGE THE COCR 12/14 FEM HEAD 36MM +0 AND R3 20 DEG XLPE ACET LNR 36MM X 56MM. THE ACETABULAR INSERT WAS REPLACED BY AN ANTEVERTED INSERT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 17393508 ↗
• InjuryJun 29, 2023Migration; Migration

  IT WAS REPORTED THAT, DURING A THR REVISION SURGERY PERFORMED ON (B)(6) 2023 DUE TO DISLOCATION IN WHICH A NEW FEMORAL HEAD WAS PLACED, IT WAS OBSERVED THAT THE PRIMARY COCR 12/14 FEM HEAD 36MM +0 HAD POPPED OFF INTO THE PATIENT'S PELVIS. SINCE THE HEAD FAILED TO BE RETRIEVED DURING REVISION, AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE PRIMARY FEMORAL HEAD FROM THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 17225837 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A HIP DISLOCATION AND DISASSOCIATED THE HEAD FROM THE STEM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A COCR 12/14 FEM HEAD 36MM +0 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 17214133 ↗
• InjuryJul 22, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT HIP ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR LINER AND THE COBALT CHROME FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A NEW POLYETHYLENE LINER AND A CERAMIC FEMORAL HEAD WITH A SLEEVE. INTRAOPERATIVELY, CORROSION WAS NOTED AT THE STEM TAPER, ALTHOUGH THIS COMPONENT WAS WELL FIXED AND THERE WAS NO NEED TO REMOVE IT. SOFT TISSUES AROUND THE HIP WERE NOTICED TO BE INTACT. THE PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 15082050 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2022, THE PATIENT EXPERIENCED INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGED THE COCR 12/14 FEM HEAD 36MM +0. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14872710 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS. THE HIP DISLOCATED ON 5 SEPARATE OCCASIONS. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 IN ORDER TO SOLVE THIS ADVERSE EVENT. IT WAS FOUND THAT THE HIP WAS RELATIVELY STABLE, AND THE COCR 12/14 FEM HEAD 36MM +0 WAS REPLACED FOR A LONGER FEMORAL HEAD COMPONENT WHICH INCREASED THE STABILITY SIGNIFICANTLY. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13479846 ↗
• InjuryJun 29, 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 (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXPLANT THE 20 DEGREES XLPE ACET LNEER36MM X 56MM ((B)(4)) AND COCR 12/14 FEM HEAD 36MM +0 ((B)(4)) DUE TO SUSPECTED INFECTION. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12087661 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF A TOTAL HIP REPLACEMENT WAS PERFORMED DUE TO SEVERAL DISLOCATION. THE PATIENT PRESENTED WITH A WELL FIXED ANTHOLOGY AND R3 CUP, WHICH HAD BEEN IMPLANTED IN 2018. THE HEAD AND LINER WERE REMOVED AND A TRIAL WITH OR3O PROVED TO PROVIDED ADEQUATE ROM WITHOUT SUBLUXATION.

  Patient problems: Joint Dislocation

  MAUDE report 10904339 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION, 2 MONTHS POST TOTAL HIP ARTHROPLASTY. THE JOINT WAS WASHED OUT, AND THE FEMORAL HEAD WAS EXPLANTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10902308 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT PRESENTED A CHRONIC INFECTION IN THE RIGHT HIP. 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 10681876 ↗
• InjuryApr 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THR VIA THE POSTERIOR APPROACH USING ANTHOLOGY R3 CONSTRUCT. THE PATIENT PRESENTED LATE-ONSET INFECTION YEARS AFTER SURGERY. DR. DECIDED TO DO THE RIGHT SIDE FIRST STAGE REVISION THR, REMOVAL OF36MM +0 COCR 12/14 FEMORAL HEAD WAS PERFORMED IN SITU ON (B)(6) 2020 AT (B)(6). FULL SECOND STAGE REVISION WILL BE PERFORMED ONCE INFECTION SUBSIDES.

  Patient problems: Unspecified Infection

  MAUDE report 9926302 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A THR PROCEDURE, THE PATIENT HAS UNDERGONE RECURRENT DISLOCATIONS DUE TO SOFT TISSUE LAXITY. FOR THIS REASON, REVISION SURGERY WAS PERFORMED AND THE 36MM +0 COCR HEAD WAS REPLACED WITH A 22MM +0 OXINIUM HEAD REF 71302200 LOT 18DM01388. ALL EXPLANTED IMPLANTS HAVE BEEN DISCARDED.

  Patient problems: Joint Dislocation

  MAUDE report 9824335 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE LINER AND HEAD WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9315172 ↗
• InjuryMar 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO CHRONIC DISLOCATION OF TOTAL HIP. FEMORAL HEAD COMPONENT EXPLANTED.

  Patient problems: Injury

  MAUDE report 8401342 ↗
• InjuryFeb 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO RECURRENT DISLOCATION AND INSTABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 8365008 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022902, 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.