PERSONA TM PEGGED POROUS TIBIAL COMPONENT
Report
- Report Number
- 0001822565-2016-03103
- Event Type
- Injury
- Date Received
- September 2, 2016
- Date of Event
- August 12, 2015
- Report Date
- April 19, 2019
- Manufacturer
- ZIMMER, INC.
- Product Code
- OIY
- PMA / PMN Number
- PK121771
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 01626; 0001822565 - 2019 - 01624; 0001822565 - 2016 - 03103-1. EVALUATION OF THE RETURNED TIBIAL COMPONENT IDENTIFIED BONE CEMENT IN THE TM MATERIAL. BOTH OF THE TM PEGS HAD BEEN CUT OFF. THE FEMORAL COMPONENT HAD BONE CEMENT IN THE TM AND SURFACE BLEMISHES (NICKS, SCRATCHES) ON THE CONDYLES AND ANTERIOR FLANGE. THE ARTICULAR SURFACE HAD NICKS AND GOUGES ON THE PROXIMAL FACE AND DAMAGE TO THE DOVETAIL THAT APPEARED TO BE FROM REMOVAL OF THE DEVICE. ASSESSMENT OF X-RAYS IDENTIFIED THE FEMORAL COMPONENT SAGITTAL ALIGNMENT IS APPROXIMATELY 2 DEGREE FLEXION AND THAT THE ANTERIOR FLANGE IS NOT FLUSH WITH THE VENTRAL CORTEX OF THE FEMUR, WHICH CAN BE A SOURCE OF KNEE PAIN. THE REVIEW ALSO NOTED THE TIBIAL COMPONENT CORONAL ALIGNMENT WAS 6 DEGREES VARUS AND MEDIAL OVERHANG OF THE TIBIAL TRAY WAS PRESENT, WHICH CAN BE A SOURCE OF KNEE PAIN. REVIEW OF THE REVISION SURGERY NOTES IDENTIFIED THE COMPONENT ALIGNMENT WAS NOT DESCRIBED OR LISTED AS AN INDICATION FOR REVISION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PER THE PERSONA KNEE SYSTEM PACKAGE INSERT PAIN IS A KNOWN POTENTIAL ADVERSE EFFECT OF THIS PROCEDURE. THE UPDATED INFORMATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSIONS. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: PERSONA TRABECULAR METAL FEMUR CRUCIATE RETAINING, CATALOG #42502206001 LOT #62789579; PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 10MM HEIGHT, CATALOG #42512000510 LOT #62762714; NEXGEN TRABECULAR METAL PRIMARY PATELLA, CATALOG #00587806535 LOT #62688970. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF OPERATIVE NOTES PROVIDED FOR EVALUATION. REVIEW OF PRIMARY SURGERY OP-NOTES IDENTIFIED NO COMPLICATIONS OR DEVIATIONS IN THE SURGERY. REVIEW OF REVISION SURGERY OP-NOTES IDENTIFIED THERE IS PAIN WITH PALPATION OVER THE MEDIAL AND LATERAL JOINT LINE AND PATELLO FEMORAL ARTICULATION. IT IS ALSO NOTED THAT THERE WERE NO SIGNS OF LOOSENING OF THE COMPONENTS OR ANY INFECTION. DEVICE HISTORY RECORD 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 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.
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT IS REPORTED THAT THE PATIENT HAD A REVISION OF HER TOTAL KNEE ARTHROPLASTY DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577015 | PERSONA TM PEGGED POROUS TIBIAL COMPONENT | KNEE PROSTHESIS | OIY | ZIMMER, INC. | 62584835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| R |