OPTETRAK LOGIC
Report
- Report Number
- 1038671-2023-01124
- Event Type
- Injury
- Date Received
- May 24, 2023
- Date of Event
- January 11, 2022
- Report Date
- June 24, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862001733
- PMA / PMN Number
- K033883
- Removal / Correction Number
- Z-0021-2022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 501
Narratives
H6: THE REVISION REPORTED MAY HAVE BEEN DUE TO THIRD BODY WEAR, PATIENT RELATED CONDITIONS, INSTABILITY, AND/OR MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, WHICH LED TO PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICE/RADIOGRAPHS WERE NOT PROVIDED.
D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITTANTS: 02-010-01-0220 - FEMUR PS CEM.Nº2 IZQ. 3887230. 02-012-45-2030 - BANDEJA TIBIAL LOGIC FIT 2F/3T 3920686. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. THE WEAR PRESENT ON THE ARTICULAR SURFACES WAS MOST LIKELY THE RESULT OF THIRD-BODY WEAR, BUT THIS CANNOT BE CONFIRMED FROM THE PROVIDED INFORMATION. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CLINICAL, COMPONENT, AND INVESTIGATION CODES. THE FOLLOWING SECTIONS WERE CORRECTED: H3: INVESTIGATION COMMENTS. H6: CLINICAL CODE: INSUFFICIENT INFORMATION, COMPONENT: LINER, INVESTIGATION FINDINGS: NO FINDINGS AVAILABLE, PACKAGING MATERIALS PROBLEM, INVESTIGATION CONCLUSION: KNOWN INHERENT RISK OF DEVICE NO LONGER APPLY.
DURING THE WEEK OF (B)(6) , REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 02-012-35-2011-INSERTO TIBIAL LOGIC PS 2,11 MM, SERIAL NUMBER (B)(4) ON(B)(6) 2015. THE INSERT WAS MANUFACTURED ON 4/18/2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 4/18/2015 AND WAS 0.39 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2022, APPROXIMATELY 7.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.
IN A 2017 FOLLOW UP, THE PATIENT HAD NO PAIN, SLIGHT LYSIS IN THE INTERNAL PLATEAU NOTED. IN 2018, THE PATIENT HAD PAIN AND INFLAMMATION, IN 2019 LYSIS WAS OBSERVED IN THE INTERNAL PLATEAU BY X-RAY, IN 2021, IT WAS OBSERVED THAT THERE WAS ASYMMETRY IN THE POLY AND LYSIS OF THE INTERNAL PLATEAU. THE LEFT KNEE REVISION SURGERY WAS PERFORMED WITH A COMPETITOR¿S SLEEVES. SYNOVITIS NOTED. PATHOLOGICAL ANATOMY CONFIRMED SYMPTOMS COMPATIBLE WITH POLYETHYLENE DISEASE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN BECAUSE THE SURGEON DID NOT WANT TO PROVIDE IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760294 | OPTETRAK LOGIC | SEE H10 | JWH | EXACTECH, INC. | LOGIC TIBIA PS MOD INSRT SZ 2 11MM | UNK | 10885862001733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |