LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
Report
- Report Number
- 1038671-2023-00740
- Event Type
- Injury
- Date Received
- April 18, 2023
- Date of Event
- December 14, 2022
- Report Date
- January 2, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862144379
- PMA / PMN Number
- K111400
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
PENDING INVESTIGATION. D10. CONCOMITANTS: 4695534, 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5; 5602889, 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T; 5545398, 200-02-29 - THREE PEG PATELLA 29MM.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FRACTURE OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
LEGAL CASE (B)(6) RK REV. AS REPORTED VIA LEGAL DOCUMENTATION: PRE & POST OPERATIVE DIAGNOSIS: RIGHT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE FAILURE. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 79-YEAR-OLD FEMALE WITH HISTORY OF RIGHT TOTAL KNEE ARTHROPLASTY, WHICH INITIALLY PERFORMED WELL AND THEN RESULTANTLY STARTING TO HAVE PAIN AND EFFUSION. A WORKUP OF THE FUSION WITH ESR AND CRP WAS PERFORMED, WHICH WAS NEGATIVE FOR INFECTION AND ALSO A CT SCAN TO EVALUATE FOR OSTEOLYSIS AND LOOSENING, WHICH WAS NO SIGNIFICANT OF EITHER. MEDIAL PART OF THE POLYETHYLENE RECALL WITHIN THE FUSION THAT IS CONSTANT WITHOUT OTHERWISE ANY OTHER ETIOLOGY. THE PATIENT DID ALSO HAVE SOME ASYMMETRY ON THE POLYETHYLENE ON THE STANDING X-RAY. BECAUSE OF ALL THESE THINGS, THE NEED FOR POLYETHYLENE EXCHANGE AND ASSOCIATED SYNOVECTOMY WAS EXPRESSED. FROM PROCEDURE IN DETAIL: DURING MEDIAL PARAPATELLAR ARTHROTOMY, A LARGE AFFUSION WITH NO PURULENCE OR METALLOSIS COULD QUICKLY BE SEEN. UPON REMOVAL OF THE POLYETHYLENE, IT WAS STATED "WE COULD EASILY SEE DESTRUCTION OF THE MEDIAL COMPARTMENT WITH DELAMINATION AND PITTING AND DISCOLORATION OR FRACTURE OF THE POSTERIOR LIP OF THE POLYETHYLENE." INSPECTION OF THE TIBIAL TRAY DID NOT YIELD ANY METALLIC FALLING OFF OF IT. PATIENT TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS OCCURRED THROUGHOUT THE CASE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO ADDITIONAL INFORMATION AVAILABLE. (B)(4), 02-012-48-1509 - LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM. SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K111400. CONCOMITANTS: 4695534, 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5; 5602889, 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T; 5545398, 200-02-29 - THREE PEG PATELLA 29MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1045055 | LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED | JWH | EXACTECH, INC. | N/A | UNK | 10885862144379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Hospitalization| R | SEE H10 |