TRIATHLON CR X3 TIBIAL INSERT
Report
- Report Number
- 0002249697-2021-01035
- Event Type
- Injury
- Date Received
- June 15, 2021
- Date of Event
- April 14, 2021
- Report Date
- December 16, 2021
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- UDI-DI
- 07613327050530
- PMA / PMN Number
- K141056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
REPORTED EVENT; AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT OF INSTABILITY WAS NOT CONFIRMED, WHILE THE EVENT OF WEAR WAS CONFIRMED VIA EVALUATION OF THE RETURNED DEVICE. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE INSERT WITHOUT ITS LOCKING WIRE WAS RETURNED FOR EVALUATION. DISCOLORATION AND DAMAGE CONSISTENT WITH IN VIVO USE AND EXPLANTATION PROCESS IS VISIBLE ON THE DEVICE. EXAMINATION BY ENGINEER INDICATED COMMON DAMAGE MODES OF UHMWPE PRESENT ON THE RETURNED DEVICE. EXPLANTATION DAMAGE WAS ALSO OBSERVED ON THE INSERT. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. -CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: CONFIRMATION: A REVISION SURGERY CANNOT BE CONFIRMED WITHOUT ADDITIONAL MEDICAL RECORDS. THAT SAID, A POLYETHYLENE TIBIAL INSERT WAS PROVIDED WITH SIGNIFICANT WEAR POSTERIORLY AND THIS WOULD MATCH/EXPLAIN THE FINDINGS ON AN X-RAY PROVIDED. ROOT CAUSE: IF THE REVISION WERE CONFIRMED AND THE POLYETHYLENE IN THE PHOTOS WAS FROM THE X-RAYS PRESENTED, THE ROOT CAUSE OF THE REVISION WOULD BE POLYETHYLENE WEAR/FAILURE POSTERIORLY. THIS COULD CERTAINLY EXPLAIN A FINDING OF INSTABILITY. THE REASON FOR THE MARKED POLY WEAR CANNOT BE DETERMINED WITHOUT ADDITIONAL MATERIALS. -DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. THE INSERT WITHOUT ITS LOCKING WIRE WAS RETURNED FOR EVALUATION. DISCOLORATION AND DAMAGE CONSISTENT WITH IN VIVO USE AND EXPLANTATION PROCESS IS VISIBLE ON THE DEVICE. EXAMINATION BY ENGINEER INDICATED COMMON DAMAGE MODES OF UHMWPE PRESENT ON THE RETURNED DEVICE. EXPLANTATION DAMAGE WAS ALSO OBSERVED ON THE INSERT. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. CLINICIAN REVIEW INDICATES THAT A POLYETHYLENE TIBIAL INSERT WAS PROVIDED WITH SIGNIFICANT WEAR POSTERIORLY AND THIS WOULD MATCH/EXPLAIN THE FINDINGS ON AN X-RAY PROVIDED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
REPORTED EVENT; AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE INSERT WITHOUT ITS LOCKING WIRE WAS RETURNED FOR EVALUATION. DISCOLORATION AND DAMAGE CONSISTENT WITH IN VIVO USE AND EXPLANTATION PROCESS IS VISIBLE ON THE DEVICE. EXAMINATION BY ENGINEER INDICATED COMMON DAMAGE MODES OF UHMWPE PRESENT ON THE RETURNED DEVICE. EXPLANTATION DAMAGE WAS ALSO OBSERVED ON THE INSERT. BASED ON THE GIVEN INFORMATION, NO IDENTIFIABLE MATERIALS OR MANUFACTURING DISCREPANCIES WERE OBSERVED ON THE SURFACES EXAMINED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: THE EVENT COULD NOT BE CONFIRMED AS INSUFFICIENT INFORMATION WAS PROVIDED.. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PRE- AND POST-OPERATIVE X-RAYS, PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
REVISION OF INSERT DUE TO INSTABILITY.
REVISION OF INSERT DUE TO INSTABILITY.
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED.
REVISION OF INSERT DUE TO INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 900120 | TRIATHLON CR X3 TIBIAL INSERT | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO | MBH | STRYKER ORTHOPAEDICS-MAHWAH | 5530-G-509 | 2855T1 | 07613327050530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Hospitalization| R |