VG DA 360 O/S TIB TRAY COCR 75
Report
- Report Number
- 3002806535-2021-00431
- Event Type
- Injury
- Date Received
- October 1, 2021
- Report Date
- December 3, 2021
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JWH
- PMA / PMN Number
- N/A
- 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). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THIS DEVICE IS USED FOR TREATMENT. NO COMPATIBILITY ISSUES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (1) SIMILAR COMPLAINT FOR ITEM #161431 (INCLUDING INITIATING COMPLAINTS), AND (1) SIMILAR COMPLAINT FOR ITEM #161449 (INCLUDING INITIATING COMPLAINTS). A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND FURTHER INVESTIGATED. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00432-1. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3 YEARS POSTOP, THE PATIENT UNDERWENT A MANIPULATION UNDER ANAESTHESIA WITH 48 HOURS OF INPATIENT PHYSICAL THERAPY DUE TO LIMITED FLEXION AND EXTENSION. THE PATIENT CONTINUED TO EXPERIENCED A DECREASE IN RANGE OF MOTION WITH DEBILITATING PAIN AND INABILITY TO PERFORM ADLS. AT THE 7 YEAR FOLLOW UP THE PATIENT STATES THAT DUE TO RHEUMATOID ARTHRITIS THEY ARE ALWAYS IN PAIN AND HAVE DIFFICULTY WALKING AND RISING ETC. BUT THE KNEE NEVER GIVES ANY PROBLEMS WITH PAIN OR MOVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
(B)(4). INITIAL REPORT SOURCE - FOREIGN: (B)(6). MEDICAL PRODUCT: VNGD SSK 360 FEMUR L 67.55 CATALOG #: 185285 LOT: 3444874; BMT SMOOTH KNEE STEM 14X80 CATALOG #: 145024 LOT: 304650; BIOMET SMOOTH KNEE STEMS 10X40 CATALOG #: 145000 LOT: 458990; BMT 360 TIB 5.0 OFFSET ADAPTER CATALOG #: 185211 LOT: 497590; VG DA360 TIB BRG ARCM 71/75X16 CATALOG #: 161449 LOT: 3267971. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00432. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAIN IMPLANTED.
IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3 YEARS POSTOP, THE PATIENT UNDERWENT A MANIPULATION UNDER ANAESTHESIA WITH 48 HOURS OF INPATIENT PHYSICAL THERAPY DUE TO LIMITED FLEXION AND EXTENSION. THE PATIENT CONTINUED TO EXPERIENCED A DECREASE IN RANGE OF MOTION WITH DEBILITATING PAIN AND INABILITY TO PERFORM ADLS. AT THE 7 YEAR FOLLOW UP THE PATIENT STATES THAT DUE TO RHEUMATOID ARTHRITIS THEY ARE ALWAYS IN PAIN AND HAVE DIFFICULTY WALKING AND RISING ETC. BUT THE KNEE NEVER GIVES ANY PROBLEMS WITH PAIN OR MOVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1463746 | VG DA 360 O/S TIB TRAY COCR 75 | KNEE PROTHESIS | JWH | BIOMET UK LTD. | N/A | 3548240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Hospitalization| R | SEE H10 NARRATIVE |