VANGUARD FEM PEGS SET 2
Report
- Report Number
- 0001825034-2024-00072
- Event Type
- Injury
- Date Received
- January 10, 2024
- Date of Event
- December 18, 2023
- Report Date
- June 18, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- K113550
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, G3, H2, H6. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED WITH THE PROVIDED INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE MADE. VISUAL EVALUATIONS OF THE PROVIDED PHOTOS FOUND EVIDENCE OF USE (SURGICAL DEBRIS); HOWEVER, NO FURTHER INFORMATION COULD BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED DUE TO NO LOT NUMBER PROVIDED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. IT WAS IDENTIFIED THAT THERE WAS POSSIBLE EVIDENCE OF RADIOLUCENCY ALONG THE TIBIAL STEM COMPONENT, NO DISLOCATION, NO DEFINITE FRACTURE, AND POSSIBLE LOOSENING OF THE TIBIAL COMPONENT. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). D10: MEDICAL PRODUCT: VAN PS OPEN INTL FEM-LT 65: CATALOG#183128, LOT#324010; VNGD PS+ TIB BRG 20X71/75MM: CATALOG#183750, LOT#794070; BIOMET OFFSET TIBIAL TRAY 75MM: CATALOG#141484, LOT#NI; OFFSET TIB TRAY 2.5MM ADAPTOR: CATALOG#141490, LOT#NI; BMT SPLINED KNEE STM 14X80: CATALOG#141614, LOT#NI. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00070; 0001825034-2024-00071. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION PER HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWINGS SECTIONS HAVE BEEN UPDATED: THE INVESTIGATION IS IN PROCESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.
NO ADDITIONAL INFORMATION TO REPORT.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY AND A DEFICIENT MEDIAL COLLATERAL LIGAMENT. THE FEMORAL COMPONENTS AND ARTICULAR SURFACE WERE REPLACED WITHOUT REPORTED COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2551424 | VANGUARD FEM PEGS SET 2 | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H | SEE H10 NARRATIVE. |