VNGD CR TIB BRG 12X71/75
Report
- Report Number
- 0001825034-2022-02189
- Event Type
- Injury
- Date Received
- September 29, 2022
- Date of Event
- April 1, 2022
- Report Date
- January 6, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- UDI-DI
- 00880304271142
- PMA / PMN Number
- K171054
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). (B)(6). LITERATURE SHARMA A, KILLAMPALLI V, PATEL A, LOCKING MECHANISM FAILURE BETWEEN TIBIAL BASEPLATE AND POLYETHYLENE INSERT IN CRUCIATE RETAINING TOTAL KNEE ARTHROPLASTY, JOURNAL OF CLINICAL ORTHOPAEDICS AND TRAUMA (2022), DOI: HTTPS://DOI.ORG/10.1016/J.JCOT.2022.102013 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: 183028 - VANGUARD CR ILOK FEM-LT 65 - J6828862. 141254 - POLISHED FINNED TIB TRAY 75MM - 2020031003. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: 183028 - VANGUARD CR ILOK FEM-LT 65 - J6828862. 141254 - POLISHED FINNED TIB TRAY 75MM - 2020031003. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: 10 MONTHS POST OP PATIENT DEVELOPED PAIN IN KNEE, PERSISTENT SWELLING NOTED, NO RESTRICTION OF ROM, X-RAYS REVEALED LOCKING BAR BACKED OUT MEDIALLY; PIN WAS FOUND RENTING THROUGH TISSUES AND THROUGH MEDIAL SOFT TISSUE ENVELOPE, REMOVED. MEMBRANE WAS FOUND BETWEEN THE ARTICULATIONS ON BOTH MEDIAL/LATERAL SIDES AND REMOVED. 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.
IT WAS REPORTED THROUGH A SINGLE CASE STUDY PUBLICATION THAT A PATIENT UNDERWENT A LEFT CRUCIATE-RETAINING TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. APPROXIMATELY 10 MONTHS LATER, THE PATIENT PRESENTED WITH PAIN, TIGHTNESS, AND PERSISTENT SWELLING. INFECTION WAS RULED OUT, AND A BACKED OUT LOCKING BAR WAS IDENTIFIED RADIOGRAPHICALLY, WHICH WAS ALSO PALPABLE SUBCUTANEOUSLY. THE PATIENT UNDERWENT REVISION OF THE POLY BEARING AND LOCKING BAR ON AN UNKNOWN DATE. DURING THE REVISION, THE BEARING WAS DOWNSIZED WHICH PROVIDED A BETTER OVERALL FIT. AT FINAL FOLLOW UP, ALL SYMPTOMS HAD SUBSIDED, AND THE PATIENT REPORTED NO FURTHER COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2934818 | VNGD CR TIB BRG 12X71/75 | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | N/A | 393660 | 00880304271142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Hospitalization| R |