OXFORD ANAT BRG RT SM SIZE 3 PMA
Report
- Report Number
- 3002806535-2024-00110
- Event Type
- Injury
- Date Received
- March 25, 2024
- Date of Event
- February 29, 2024
- Report Date
- July 26, 2024
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- UDI-DI
- 05019279786145
- PMA / PMN Number
- P010014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2024-00111-2, 3002806535-2024-00112-2. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED SIGNS OF USE (NICKED, GOUGED) AND CONFIRMING COMPLAINT HAS SIGNIFICANT WEAR. DUE TO WEAR NO MEASUREMENTS TAKEN. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED TWO VIEWS RIGHT KNEE DATED OVER FOUR (4) YEARS AFTER IMPLANTATION DEMONSTRATES A MEDIAL COMPARTMENT HEMIARTHROPLASTY WITH RADIOLUCENCY ALONG THE CEMENT HARDWARE INTERFACE OF THE TIBIAL COMPONENT. JOINT SPACE NARROWING COULD INDICATE POLYETHYLENE WEAR. TWO VIEWS RIGHT KNEE DATED ABOUT SIX (6) YEARS AFTER IMPLANTATION DEMONSTRATES MEDIAL COMPARTMENT HEMIARTHROPLASTY WITH PERSISTENT FINDINGS OF POLYETHYLENE WEAR AND POSSIBLE LOOSENING OF THE TIBIAL COMPONENT. TWO VIEWS RIGHT KNEE DATED ELEVEN (11) YEARS AFTER IMPLANTATION DEMONSTRATES MEDIAL COMPARTMENT HEMIARTHROPLASTY WITH PERSISTENT FINDINGS OF POLYETHYLENE WEAR AND POSSIBLE LOOSENING OF THE TIBIAL COMPONENT. MEDIAL COMPARTMENT HEMIARTHROPLASTY OF THE RIGHT KNEE WITH POSSIBLE POLYETHYLENE WEAR AND LOOSENING OF THE TIBIAL COMPONENT. SIZING IS APPROPRIATE. MILD OSTEOPENIA. THERE IS POSSIBLE POLYETHYLENE WEAR AND LOOSENING OF THE TIBIAL COMPONENT. POSSIBLE POLYETHYLENE WEAR AND LOOSENING OF THE TIBIAL COMPONENT. BOTH OF THESE FINDINGS CAN CAUSE PAIN. WITH GIVEN INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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). D10 - ASSOCIATED MEDICAL DEVICES: OXF UNI TIB TRAY SZ B RM PMA; ITEM# 154721; LOT# UNKNOWN. OXF TWIN-PEG CMNTD FEM SM PMA; ITEM# 161468; LOT# UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2024-00111 3002806535-2024-00112 INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT TEN YEARS AND SIX MOST POST PARTIAL KNEE ARTHROPLASTY, THE PATIENT HAD TO UNDERGO A REVISION DUE TO PAIN. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS SOME WEAR TO THE BEARING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10753 | OXFORD ANAT BRG RT SM SIZE 3 PMA | KNEE PROSTHESIS | NRA | BIOMET UK LTD. | 2682445 | 05019279786145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | Hospitalization| R | SEE H10 NARRATIVE. |