TRABECULAR METAL TIBIAL CONE MEDIUM
Report
- Report Number
- 3005751028-2018-00065
- Event Type
- Injury
- Date Received
- November 20, 2018
- Date of Event
- October 15, 2018
- Report Date
- April 28, 2020
- Manufacturer
- ZIMMER TMT
- Product Code
- JWH
- PMA / PMN Number
- K053340
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
INFORMATION WITHIN ETQ WAS REVIEWED, THE 2 PHOTOGRAPHS OF AN ALL-POLY PATELLA WHICH WERE ATTACHED TO THE COMPLAINT WERE REVIEWED, THE USAGE REPORTS WERE REVIEWED, THE HAND-WRITTEN OPERATIVE NOTES WERE REVIEWED, THE SUPERB HAND-DRAWN SKETCH OF THE TIBIA AND FEMUR WITH ALL IMPLANTS IDENTIFIED WAS REVIEWED AND THE ROTATING HINGE KNEE (RHK) TIBIAL AUGMENT SIZE INTERCHANGEABILITY CHART (97-5880-08 ©2002) WAS REVIEWED TO DETERMINE COMPATIBILITY. ON (B)(6) 2016 PATIENT¿S RIGHT KNEE WAS REVISED A FIRST TIME TO A RHK SIZE F, RIGHT SIDE FEMORAL COMPONENT WITH AUGMENTATION AND A RHK POLY ARTICULAR SURFACE SIZE F, 14MM HEIGHT AND A RHK SIZE 4 TIBIAL COMPONENT. A TRABECULAR METAL MEDIUM TIBIAL CONE (46X34X25MM) WAS ALSO IMPLANTED. THERE IS NO RECORD OF A POLY PATELLA BEING IMPLANTED YET THE 2 PHOTOGRAPHS THAT WERE ATTACHED TO THE COMPLAINT CLEARING SHOW A FAILED ALL-POLY PATELLA. ON (B)(6) 2018 PATIENT¿S RIGHT KNEE WAS REVISED A SECOND TIME. THE ONLY COMPONENTS THAT WERE IMPLANTED DURING THIS PROCEDURE WAS A CEMENTED ALL-POLY PATELLA SIZE 32MM, 8.5MM THICK AND RHK POLY ARTICULAR SURFACE SIZE F, 14MM HEIGHT ONLY. THE SURGEON WAS MADE AWARE DURING THE PROCEDURE THAT THE POLY WAS NOT COMPATIBLE WITH THE BASE PLATE BUT THE SURGEON ACCEPTED RESPONSIBILITY FOR THE OFF-LABEL USE. NOTE THAT THE RHK SIZE 4 POLY ARTICULATING SURFACE WAS COMPATIBLE WITH THE RHK SIZE 4 TIBIAL BASE PLATE. HOWEVER, IT WAS CONFIRMED VIA THE ROTATING HINGE KNEE (RHK) TIBIAL AUGMENT SIZE INTERCHANGEABILITY CHART (97-5880-08 ©2002) THAT A RHK SIZE F FEMORAL COMPONENT IS NOT COMPATIBLE WITH A RHK SIZE 4 TIBIAL COMPONENT. THE TM CONE THAT WAS IMPLANTED ON (B)(6) 2016 WAS COMPATIBLE WITH THE RHK. THERE IS NO EVIDENCE THAT THE TM CONE WAS EXPLANTED OR FAILED TO PERFORM AS INTENDED. THIS INVESTIGATION BY PRODUCT DEVELOPMENT/POST-MARKET ENGINEERING IS CONSIDERED CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION MAY BE RE-OPENED.
UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.
IT WAS REPORTED THAT PATIENT WAS REVISION DUE TO ANTERIOR KNEE PAIN.
UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.
CONCOMITANT MEDICAL PRODUCTS: TRABECULAR TIBIAL CONE, MEDIUM 46X34MM ITEM # 00545001346 LOT # 63020485. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE HOSPITAL REFUSES TO RETURN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.
IT WAS REPORTED THAT PATIENT WAS REVISION DUE TO ANTERIOR KNEE PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 929967 | TRABECULAR METAL TIBIAL CONE MEDIUM | PROSTHESIS KNEE | JWH | ZIMMER TMT | 63020485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |