UNKNOWN NEXGEN RHK FEMORAL COMPONENT
Report
- Report Number
- 0001822565-2022-00192
- Event Type
- Injury
- Date Received
- February 8, 2022
- Report Date
- February 23, 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.
(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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H10 THE INVESTIGATION RESULTS REMAIN UNCHANGED. THIS REPORT WAS SUBMITTED TO REPORT ASSOCIATED MDR REPORT BELOW. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00405.
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 3 PATIENTS EXPERIENCED A PERIPROSTHETIC FEMORAL FRACTURE AND WERE TREATED CONSERVATIVELY. 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 FINLAND THAT LOOKED AT SURVIVAL RATE AND OUTCOMES IN REVISION ROTATING HINGE KNEE (RHK) ARTHROPLASTIES. THE STUDY REPORTED 3 PATIENTS EXPERIENCED A PERIPROSTHETIC FEMORAL FRACTURE AND WERE TREATED CONSERVATIVELY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1776517 | UNKNOWN NEXGEN RHK FEMORAL COMPONENT | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R |