VANGUARD PS OPEN BOX FEMORAL 65MM RIGHT ¿ INTERLOK FOR CEMENTED USE
Report
- Report Number
- 0001825034-2016-04791
- Event Type
- Injury
- Date Received
- December 1, 2016
- Date of Event
- July 16, 2015
- Report Date
- October 1, 2017
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PK023546
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- ATTORNEY
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, AND LOOSENING OF THE FEMORAL COMPONENTS. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IMPLANT DATE: (B)(6) 2008. UNABLE TO CONFIRM COMPLAINT. CONCOMITANT MEDICAL PRODUCTS-AGC PATELLA ARCOM POLY. WITH WIRE 34 MM CATALOG 11-150828 LOT 653030; BMT SPLINED KNEE STM 80 X 20 MM CATALOG 141620 LOT 187910, DEPUY SMARTSET BONE CEMENT CATALOG# 545050500 LOT# 2482478, DEPUY SMARTSET BONE CEMENT CATALOG# 545050500 LOT# 2482479, BIOMET STEMMED TIBIAL PLATE CATALOG# 141514 LOT# 161550. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-03208.
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION OR EXCESSIVE ACTIVITY.¿ NUMBER 15 STATES, ¿INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ CONCOMITANT MEDICAL PRODUCTS - AGC PATELLA ARCOM POLY. WITH WIRE 34MM CATALOG 11-150828 LOT 653030; BMT SPLINED KNEE STM 80X20MM CATALOG 141620 LOT 187910. THIS REPORT IS NUMBER 1 OF 8 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04791 / 04798).
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DEATH WAS REPORTED APPROXIMATELY ONE MONTH POST REVISION.
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [LOCATION UNKNOWN] TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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.
LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, AND LOOSENING OF THE FEMORAL COMPONENTS. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED
LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, AND LOOSENING. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, NICKEL ALLERGY, AND LOOSENING OF THE FEMORAL COMPONENTS. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. LEGAL COUNSEL ALSO REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN REASONS APPROXIMATELY ONE MONTH POST REVISION.
LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, DYSFUNCTION, NICKEL ALLERGY, LIMITED RANGE OF MOTION AND LOOSENING OF THE FEMORAL COMPONENTS. A REVIEW OF INVOICE HISTORY CONFIRMS TIBIAL TRAY, PATELLA, BEARING AND FEMUR WERE REMOVED AND REPLACED. LEGAL COUNSEL ALSO REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN REASONS APPROXIMATELY ONE MONTH POST REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 787998 | VANGUARD PS OPEN BOX FEMORAL 65MM RIGHT ¿ INTERLOK FOR CEMENTED USE | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | N/A | 506070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death| H| R |