LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM
Report
- Report Number
- 1038671-2024-02403
- Event Type
- Injury
- Date Received
- July 18, 2024
- Date of Event
- July 16, 2024
- Report Date
- November 8, 2024
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862159335
- PMA / PMN Number
- K111400
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
D10 CONCOMITANT DEVICES (5241951) 02-012-45-3545 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 4.5T ; (5343760) 200-02-32 - THREE PEG PATELLA 32MM; (5361734) 02-010-03-0235 - LOGIC CR FEMORAL CEM, LEFT, SZ 3.5. 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 DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
H6: CORRECTED HEALTH EFFECT IMPACT CODE, TYPE OF INVESTIGATION. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND/OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.
THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND/OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.
"LEGAL CASE ¿ USA (MDL NO. 3044) PATIENT ID: (B)(6) + LEFT KNEE (B)(4) RK REV IS ASSOCIATED WITH THIS CASE" "THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE" "THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022 02-012-49-3513 - LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM SERIAL:(B)(6). 510K: K111400 UDI: (B)(4). PRODUCT CODE: JWH X-RAY: NO OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (5241951) 02-012-45-3545 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 4.5T, (5343760) 200-02-32 - THREE PEG PATELLA 32MM, (5361734) 02-010-03-0235 - LOGIC CR FEMORAL CEM, LEFT, SZ 3.5".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2150257 | LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. | 10885862159335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | SEE H11. |