UNKNOWN TIBIAL TRAY
Report
- Report Number
- 0001822565-2022-00313
- Event Type
- Injury
- Date Received
- February 10, 2022
- Report Date
- February 10, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). REPORT SOURCE: FOREIGN - (B)(6). LITERATURE - VON HINTZE, J., NIEMELÄINEN, M., SINTONEN, H., NIEMINEN, J., & ESKELINEN, A. (2021). OUTCOMES OF THE ROTATING HINGE KNEE IN REVISION TOTAL KNEE ARTHROPLASTY WITH A MEDIAN FOLLOW-UP OF 6.2 YEARS. BMC MUSCULOSKELETAL DISORDERS, 22(1), 336. HTTPS://DOI.ORG/10.1186/S12891-021-04205-9. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00312, 0001822565-2022-00314, 0001822565-2022-00315, 0001822565-2022-00382.
(B)(4). REPORT SOURCE: FOREIGN - (B)(6). LITERATURE - VON HINTZE, J., NIEMELÄINEN, M., SINTONEN, H., NIEMINEN, J., & ESKELINEN, A. (2021). OUTCOMES OF THE ROTATING HINGE KNEE IN REVISION TOTAL KNEE ARTHROPLASTY WITH A MEDIAN FOLLOW-UP OF 6.2 YEARS. BMC MUSCULOSKELETAL DISORDERS, 22(1), 336. HTTPS://DOI.ORG/10.1186/S12891-021-04205-9. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00312, 0001822565-2022-00314, 0001822565-2022-00315, 0001822565-2022-00382.
A JOURNAL ARTICLE WAS RETRIEVED FROM BMC MUSCULOSKELETAL DISORDERS (2021) THAT REPORTED A STUDY FROM FINLAND THAT LOOKED AT SURVIVAL RATE AND OUTCOMES IN REVISION ROTATING HINGE KNEE (RHK) ARTHROPLASTIES. THE STUDY REPORTED THREE PATIENTS EXPERIENCED PERIPROSTHETIC JOINT INFECTIONS. ONE PATIENT WAS TREATED WITH A COURSE OF ANTIBIOTICS. TWO PATIENTS DECLINED OPERATIVE TREATMENT AND WERE PRESCRIBED PERMANENT ORAL ANTIBIOTIC TREATMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
A JOURNAL ARTICLE WAS RETRIEVED FROM BMC MUSCULOSKELETAL DISORDERS (2021) THAT REPORTED A STUDY FROM (B)(6) THAT LOOKED AT SURVIVAL RATE AND OUTCOMES IN REVISION ROTATING HINGE KNEE (RHK) ARTHROPLASTIES. THE STUDY REPORTED THREE PATIENTS EXPERIENCED PERIPROSTHETIC JOINT INFECTIONS. ONE PATIENT WAS TREATED WITH A COURSE OF ANTIBIOTICS. TWO PATIENTS DECLINED OPERATIVE TREATMENT AND WERE PRESCRIBED PERMANENT ORAL ANTIBIOTIC TREATMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 876247 | UNKNOWN TIBIAL TRAY | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |