UNKNOWN NEXGEN ROTATING HINGE KNEE TIBIAL COMPONENT
Report
- Report Number
- 0001822565-2022-00323
- Event Type
- Injury
- Date Received
- February 10, 2022
- Date of Event
- July 29, 2021
- Report Date
- February 10, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- NI
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). DAUWE, J., VANDEKERCKHOVE, B., BOUTTELGIER, R., HOLZER, L. A., DAUWE, D., VANDENNEUCKER, H. (29 JUL 2021). PATIENT-REPORTED OUTCOMES AFTER PRIMARY ROTATING HINGE TOTAL KNEE ARTHROPLASTY: A MULTI-CENTRE CLINICAL COHORT STUDY. INTERNATIONAL ORTHOPAEDICS. 45 (11), 2893-2897. HTTPS://DOI.ORG/10.1007/S00264-021-05162-7. CONCOMITANT DEVICES - UNKNOWN NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN ZIMMER NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE CATALOG #: NI LOT #: NI, UNKNOWN PATELLA CATALOG #: NI LOT #: NI, UNKNOWN NEXGEN FEMORAL STEM CATALOG #: NI LOT #: NI. CORRESPONDENCE AUTHOR; THE ARTICLE NOTES THAT THE MAJORITY OF THE PROCEDURES WERE PERFORMED AT (B)(6). REPORT SOURCE - FOREIGN: (B)(6). THE PRODUCT COULD NOT BE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001822565-2022-00322, 0001822565-2022-00324, 0001822565-2022-00325, 0001822565-2022-00378.
(B)(4). DAUWE, J., VANDEKERCKHOVE, B., BOUTTELGIER, R., HOLZER, L. A., DAUWE, D., VANDENNEUCKER, H. (29 JUL 2021). PATIENT-REPORTED OUTCOMES AFTER PRIMARY ROTATING HINGE TOTAL KNEE ARTHROPLASTY: A MULTI-CENTRE CLINICAL COHORT STUDY. INTERNATIONAL ORTHOPAEDICS. 45 (11), 2893-2897. HTTPS://DOI.ORG/10.1007/S00264-021-05162-7. CONCOMITANT DEVICES - UNKNOWN NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN ZIMMER NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE CATALOG #: NI LOT #: NI, UNKNOWN PATELLA CATALOG #: NI LOT #: NI, UNKNOWN NEXGEN FEMORAL STEM CATALOG #: NI LOT #: NI. CORRESPONDENCE AUTHOR; THE ARTICLE NOTES THAT THE MAJORITY OF THE PROCEDURES WERE PERFORMED AT (B)(6). REPORT SOURCE - FOREIGN: (B)(6). THE PRODUCT COULD NOT BE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001822565-2022-00322, 0001822565-2022-00324, 0001822565-2022-00325, 0001822565-2022-00378.
IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO (2) PATIENTS EXPERIENCED PAIN FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO (2) PATIENTS EXPERIENCED PAIN FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670209 | UNKNOWN NEXGEN ROTATING HINGE KNEE TIBIAL COMPONENT | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | Other |