CPS SHORT ANCHOR PLUG 10MM
Report
- Report Number
- 0001825034-2022-00282
- Event Type
- Injury
- Date Received
- February 8, 2022
- Date of Event
- January 31, 2022
- Report Date
- June 7, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWA
- UDI-DI
- 00880304508927
- PMA / PMN Number
- K062998
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT MEDICAL PRODUCTS: 178527 CPS TRANSVERSE PIN 6PK 32MM M - 297750, 178526 CPS TRANSVERSE PIN 6PK 28MM M - 803450, 178512 CPS NUT CO-CR-MO ALLOY 913320, 178710 CPS TAPER LOCKING CAP / OSS SC REW 361860, 178711 CPS/OSS 5CM TPR ADAPT W/OSS SC 5CM 490430, 161012 OSS RS 7 CM MOD SEG FMRL-LT LT 271580, 150468 OSS RS POLY FEM BUSHINGS SET/2 223620, 150493 OSS REINFORCED YOKE 103130, 150476 OSS POLY TIBIAL BUSHING 194630, 161035 OSS RS AXLE 344400, 161094 OSS RS 12MM LS TIBIAL BEARING 622880, 150478 OSS POLY LOCK PIN -634510. REPORT SOURCE FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D1; D2; D4; D9; D10; G3; G4; G6; H1; H2; H3; H4 D10: 178363 - CPS XS SHT SPDL W PINS 600LBF - 204870 PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION OF RETURNED DEVICE WAS FOUND TO EXHIBIT DAMAGE NICKED, GOUGED AND THE SHAFT IS FRACTURED OFF. ADDITIONAL TESTING OF THE PRODUCT STATES THAT FRACTURE IS DUE TO FATIGUE. FURTHER ELEMENTAL ANALYSIS OF THE CPS SHORT ANCHOR PLUG SAMPLE SHOWED THAT IT WAS CONFORMING. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. SURGICAL NOTES PROVIDED CONFIRM THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND FAILED OSS COMPRESS DISTAL FEMORAL PROSTHESIS LEFT/ RECONVERSION OSS TOTAL FEMUR PROSTHESIS. X-RAY REVIEW BY MMI CONFIRMS IMPLANT FRACTURE AND STATES THAT THERE IS DISRUPTION OF THE OSS DEVICE AT THE PROXIMAL FEMORAL JUNCTION WITH MARKED VARUS ANGULATION OF THE FEMUR. BONE QUALITY IS OSTEOPENIC. A DEFINITIVE ROOT CAUSE CANNOT 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT HAD AN OSS COMPRESS IMPLANTED 7 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A BROKEN COMPRESS PART. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1551274 | CPS SHORT ANCHOR PLUG 10MM | PROSTHESIS, KNEE | KWA | ZIMMER BIOMET, INC. | N/A | 467170 | 00880304508927 |
| 1866004 | CPS SHORT ANCHOR PLUG 10MM | PROSTHESIS, KNEE | KWA | ZIMMER BIOMET, INC. | N/A | 467170 | 00880304508927 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | Hospitalization| R | SEE H10.| SEE H10. |