OPTETRAK THREE PEG PATELLA 38MM
Report
- Report Number
- 1038671-2024-03343
- Event Type
- Injury
- Date Received
- September 6, 2024
- Date of Event
- March 1, 2023
- Report Date
- October 2, 2024
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- PMA / PMN Number
- K932690
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED AND THE COMPLETION OF INVESTIGATION, THE FOLLOWING SECTIONS G1, G3, G6, H1, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3): THE REVISION REPORTED MAY HAVE BEEN DUE TO PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT. HOWEVER, THE REPORTED EVENT CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE FULLY ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, MANUFACTURING LOT INFORMATION, OR DETAILED CLINICAL INFORMATION WAS PROVIDED.
(D10) CONCOMITANT DEVICE(S): 02-010-01-0240, LOGIC FEMORAL PS CEM LEFT SZ 4. 02-012-45-4040, LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. (H3): THE REVISION REPORTED MAY HAVE BEEN DUE TO PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENT. HOWEVER, THE REPORTED EVENT CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE FULLY ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, MANUFACTURING LOT INFORMATION, OR DETAILED CLINICAL INFORMATION WAS PROVIDED.
APPROXIMATELY 9 YEAR(S), 3 MONTH(S) AND 3 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT WAS HOSPITALIZED FOR RIGHT TOTAL KNEE REPLACEMENT (TIBIAL POLY EXCHANGE, EXTENSIVE SYNOVECTOMY AND PATELLA POLY EXCHANGE). THE PATIENT UNDERWENT REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THE LOGIC DEVICE SERIAL NUMBER IS UNKNOWN AND CANNOT BE CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. SUSPECTED DEVICE(S): P/N: 02-012-35-4013. DEVICE NAME: OPTETRAK LOGIC TIBIA PS MOD INSRT SZ 4 13MM. S/N: UNK. 510K: K033883. UDI: (B)(4). PRODUCT CODE: JWH. P/N: 200-02-38. DEVICE NAME: OPTETRAK THREE PEG PATELLA 38MM. S/N: UNK. UDI: (B)(4). 510K: K932690. PRODUCT CODE: JWH. CONCOMITANTS: 02-010-01-0240. LOGIC FEMORAL PS CEM LEFT SZ 4. 02-012-45-4040. LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. NO EBI INFO COULD BE FOUND. 66-YEAR-OLD MALE PATIENT. HEIGHT: 178 CM. WEIGHT: 99 KGS. DIAGNOSIS: PRIMARY OSTEOARTHRITIS. HAD RIGHT TKR IN 2013. A.E. 1: (B)(6) 2020 - EXCESSIVE WEAR OF IMPLANT COMPONENTS SECONDARY TO DAMAGE OF ARTICULAR SURFACES. PAIN/PULLING IN THE OPERATED KNEE, X-RAY SHOWS EXCESSIVE MEDIAL POLY WEAR. (RESOLVED (B)(6) 2021). A.E. 2-1: (B)(6) 2021 - INFLAMMATION: ARTHROSCOPIC SYNOVIAL BIOPSY OF RIGHT KNEE. THIS WAS A DAY CASE PROCEDURE, AND UPON REVIEW, WAS FOUND TO HAVE BEEN RECORDED AS INPATIENT HOSPITALIZATION. (RESOLVED (B)(6) 21). A.E. 2-2: (B)(6) 2021 - POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS. ARTHROSCOPIC SYNOVIAL BIOPSY OF RIGHT KNEE (RESOLVED (B)(6) 2021).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1066513 | OPTETRAK THREE PEG PATELLA 38MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | SEE H11 |