NA 71302800Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03596010194114), received between Nov 10, 2017 and Oct 2, 2023 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K211176, K963509); 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Adverse 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY AN INTERVENTION ON (B)(6) 2023, IN WHICH A DAIR (DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION) PROCEDURE WAS PERFORMED WITH THE EXCHANGE OF THE COCR 12/14 FEM HEAD 28 +0 AND THE TANDEM INTL BIPOLAR 43OD 28ID. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 17851784 ↗
• InjuryMar 7, 2023Adverse 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) 2023, THE PATIENT EXPERIENCED A DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO EXCHANGE ONE (1) COCR 12/14 FEM HEAD 28 +0 TO A +8MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Joint Dislocation

  MAUDE report 16496166 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT, AFTER UNDERGOING A LEFT THR REVISION SURGERY ON (B)(6) 2020 DUE TO SOCKET LOOSENING, THE PATIENT EXPERIENCED DISLOCATION/SUBLUXATION AND AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A SECOND REVISION SURGERY ON (B)(6) 2020, IN WHICH DEBRIDEMENT AND IMPLANT RETENTION (DAIR) WAS CONDUCTED. DURING THIS PROCEDURE, THE MODULAR HEAD WAS REMOVED AND REPLACED WITH A COMPETITOR'S DEVICE (MERETE MEDICAL). 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 THR REVISION SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A SECOND REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 16282998 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2020, IN WHICH THE STEM, CUP, HEAD AND LINER WERE EXPLANTED AND REPLACED WITH A NEW THR SYSTEM. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 15089965 ↗
• InjuryMay 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE TANDEM INTL BIPOLAR 44OD 28ID AND COCR 12/14 FEM HEAD 28 +0 WERE FOUND COMPLETELY LOOSE. THE IMPLANTS WERE CHANGED USING TNDM BP SHL/XLPE LNR 42OD 26ID AND COCR 12/14 FEM HEAD 22 +0. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283275 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH A COCR 12/14 FEM HEAD 28 +0 WAS EXPLANTED. MOREOVER, A KNEE FUSION FAN L 11.5MM X 75CM ALONG TWO (2) TRIGEN LOW PROFILE SCREW 5.0MM X 27.5MM WERE USED AS AN ANTIBIOTIC SPACER, AND A TEMPORARY IMPLANT WAS USED TO COUNTERACT INFECTION. PATIENT IS CURRENTLY HOSPITALIZED OVERCOMING PREVIOUS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13939449 ↗
• InjuryDec 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR, PERFORMED SIXTEEN YEAR AGO (2005), THE PATIENT EXPERIENCED 2 RECENT DISLOCATIONS, WITH THE LAST DISLOCATION APPROXIMATELY 3 WEEKS AGO. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO CHANGE REFLECTION 28MMID SIZE E XLPE 20 DEG LINER (B)(4). TO CONSTRAINED OPTION AND CHANGE COCR 12/14 FEM HEAD 28 +0 (B)(4). THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13111010 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PARTIAL ARTHROPLASTY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO REPAIR A FEMUR FRACTURE, THE PATIENT HAD TWO CONSECUTIVE FALLS AFTERWARDS, WHICH CAUSED TEARS IN ALL SOFT TISSUE SUPPORT STRUCTURES AROUND THE HIP JOINT. REDAPT SLVLS MONO STEM 240MM SZ 17 SO, COCR 12/14 FEM HEAD 28 +0 AND TANDEM INTL BIPOLAR 46OD 28ID WERE EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Rupture

  MAUDE report 13089699 ↗
• InjuryDec 16, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE COCR 12/14 FEM HEAD 28 +0 WAS FOUND COMPLETELY LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A EXPLANATION ON (B)(6) 2021. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13023142 ↗
• InjuryNov 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A DISLOCATION OF THE RIGHT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021, IN WHICH A R3 3 HOLE HA CTD ACET SHELL 46MM, REF SPHER HEAD SCREW 40MM, (2) REF SPHER HEAD SCREW 30MM, A COCR 12/14 FEM HEAD 28 +0 AND A R3 0 DEG XLPE ACET LNR 28MM X 46MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12796353 ↗
• InjuryNov 9, 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 25 YEARS AGO, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. 28 LINER AND COCR 12/14 FEM HEAD 28 +0 WERE REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12780054 ↗
• InjuryAug 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A HIP ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A DISASSOCIATION OF THE FEMORAL HEAD FROM THE BIPOLAR SHELL AS A CONSEQUENCE OF A FALL. THIS ADVERSE EVENT WAS SOLVED BY A REVISION PROCEDURE ON (B)(6) 2021 IN WHICH BOTH DEVICES WHERE REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12294344 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THR SURGERY PERFORMED FIVE WEEKS BEFORE REVISION SURGERY, THE PATIENT EXPERIENCED AN INFECTION (B)(6). THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE FOLLOWING DEVICES WERE EXPLANTED FROM THE PATIENT: CPCS SS PRIM SO 12/14 SZ 3 (CASE-(B)(4)), TANDEM BIPOLAR COCR 55OD 28ID (CASE-(B)(4)) AND COCR 12/14 FEM HEAD 28 +0 (CASE-(B)(4)). NEW DEVICES WERE IMPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 11781928 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT SEVENTEEN MONTHS AFTER A RIGHT HIP HEMIARTHROPLASTY HAD BEEN PERFORMED, A REVISION SURGERY TOOK PLACE, DUE TO THE PATIENT INCREASING GROIN PAIN AND AGE RELATED DEGENERATIVE CHANGES IN THE ACETABULUM. THE BIPOLAR HEAD WAS REMOVED AND NEW IMPLANTS WERE INSERTED. IT IS UNKNOWN THE PATIENT CURRENT HEALTH STATUS.

  Patient problems: Implant Pain

  MAUDE report 11648434 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT HAD A HEMIARTHROPLASTY AND HAD TWO PREVIOUS DISLOCATIONS, DUE TO A THIRD DISLOCATION SURGEON DECIDED TO REMOVE THE COCR 12/14 FEM HEAD 28 +0 AND THE TANDEM BIPOLAR COCR 49OD 28ID AND PUT IN CUP AND LINER TO COVERT TO A TOTAL HIP. OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11388845 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY THR, A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION. A COCR 12/14 FEM HEAD 28 +0 WAS EXPLANTED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11305595 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY, PATIENT DEVELOPED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE BALL HEAD. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10968642 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A DISLOCATION. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE ADVERSE EVENT. THE COCR 12/14 FEM HEAD 28 +0 WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 10909089 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE COCR 12/14 FEMORAL HEAD 28 +0. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10779918 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGERY WAS SCHEDULE FOR A PATIENT AFTER A PET SCAN WAS PERFORMED. CLINICAL ANALYSIS INDICATED AN INFECTION WAS PRESENT. THE DECISION WAS MADE TO REMOVE THE CUP AND LINER AS WELL AS THE FEMORAL HEAD. THE NEW IMPLANTS WERE FROM A COMPETITOR, HOWEVER A S&N FEMORAL HEAD (36MM +12) WAS IMPLANTED. 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 10439553 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN AND INSTABILITY IN THE OPERATED LEFT HIP. THE PATIENT HAD CUP AND LINER FROM ZIMMER, AND FEMORAL HEAD AND STEM FROM SMITH&NEPHEW. THE X RAYS SHOWED A DISENGAGEMENT OF THE LOCKING RING AROUND THE CONSTRAINED ZIMMER LINER, WHICH REQUIRED A NEW LINER AND FEMORAL HEAD. THE 28MM OD +0 COCR FEMORAL HEAD WAS EXPLANTED AND EXCHANGED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10399920 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR REPLACEMENT HAD BEEN PERFORMED, THE PATIENT FELL AT SOME POINT. WHEN THE SURGEON TRIED TO REDUCE THE DISLOCATION OF THE PATIENT, THE FEMORAL HEAD FAILED. THEN, A REVISION SURGERY WAS PERFORM TO EXPLANT THE DEVICE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10045904 ↗
• MalfunctionApr 11, 2020Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT DURING SURGERY, IT WAS FOUND AN INCONSISTENCY ON THE LABELING OF THE PRODUCT. THERE WAS A MARKING OF THE OUTER PACKAGING OF THE CO-CR IMPLANT AND A MARKING OF THE STERILE PACKAGING OF NOT FOR USE WITH CO-CR PARTS. A REPLACEMENT OF SMITH AND NEPHEW WAS USED. THE PATIENT WAS NOT INJURED, THE OPERATION ENDED WELL FOR HIM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9951749 ↗
• InjuryOct 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DESPITE WHAT SEEMED TO BE A SATISFACTORY IMPLANTATION, A REVISION SURGERY HAD TO BE DONE DUE TO DISLOCATION. THE BIPOLAR CUP WAS DISLOCATED AND DID NOT HAVE THE HEAD INSIDE IT WHEN THE PARTS WHERE REMOVED, DESPITE HAVING THE INTEGRAL AND WELL PLACED SAFETY RING. NEW DEVICES OF THE SAME REFERENCE WERE PLACE AS REPLACEMENT. BACK-UP AVAILABLE, NO DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 9216071 ↗
• InjuryJun 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LEFT HIP DISLOCATION OCCURRED DUE TO DISLODGEMENT OF THE FEMORAL HEAD FROM THE DUAL MOBILITY LINER.

  Patient problems: Joint Dislocation

  MAUDE report 8725674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K963509. 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.