CC TIBIAL INSERT SZ 4, 11MM
Report
- Report Number
- 1038671-2024-03269
- Event Type
- Injury
- Date Received
- September 4, 2024
- Date of Event
- March 3, 2017
- Report Date
- February 14, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- PMA / PMN Number
- K954208
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
CONCOMITANT DEVICES 02-012-42-4008 - LOGIC PTS, SIZE 4, 8MM 2355634 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 4097673 204-36-08 - STEM EXTENSION 80L X16 MM 2839276 204-40-08 - STEM EXTENSION 80L X20 MM 2253082 204-70-00 - TIBIAL STEM EXT. SCREW 3000992 208-01-04 - CC FEMORAL SZ 4 3971130 208-04-73 - SCREW, OFFSET, SZ EE 4042880 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM 2830181 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM 2830212 208-07-04 - CC POSTERIOR FEM AUGMENT SZ 4, 5MM 2322728 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE 4005750 208-24-11 - CC TIBIAL INSERT SZ 4, 11MM 3778220. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D4. THE REASON FOR THE REVISION REPORTED IN (B)(4) CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO 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 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."
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO 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 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."
COMPLAINT REVIEW NOTE-18 MAR 2024, V SIMMS, RN-COMPLAINT/ FM INSTABILITY/TO HCP /FDA REPORTABLE/ SPECIFIC DEVICE NAME IS PS/ REVISION SURGERY LK/ QAD AND EBI ATTACHED. MDL NO. 3044, CASE NO. (B)(4) SHORT FORM COMPLAINT ATTACHED./ REVISION OPERATIVE REPORT OF (B)(6) 2017 - REVISION OF LEFT TOTAL KNEE ARTHROPLASTY POLYETHYLENE/ FOR UNSTABLE LEFT TOTAL KNEE/ HE HAS DEVELOPED CLICKING AND LOOSENING OF THE LEFT KNEE IN FLEXION AND EXTENSION. PATIENT WAS UPSIZED FROM AN 11MM POLY TO A 15MM POLY. REPORT SLIGHT RECURAVATUM WITH VARUS/VALGUS STABILITY IN EXTENSION AND FLEXION. PATIENT WAS REVISED TO EXACTECH POLYETHYLENE, NO OTHER DEVICES WERE EXCHANGED. --------------------- *ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 28FEB2024. THIS PATIENT IS VERIFIED BOTH KNEES DONE BY IAN GRADISAR, MD AT CRYSTAL CLINIC IN AKRON, OH HE HAD THE LEFT KNEE REVISED ON (B)(6) 2017 BY IAN GRADISAR, MD AT CRYSTAL CLINIC IN AKRON, OH (OP REPORT ATTACHED). ITEM NUMBER AND FULL DESCRIPTION SERIAL NUMBER 204-25-11 - PS TIBIAL INSERTS SZ 5, 11MM (B)(6) ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K933610. CONCOMITANTS: 02-012-42-4008 - LOGIC PTS, SIZE 4, 8MM 2355634 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 4097673 204-36-08 - STEM EXTENSION 80L X16 MM 2839276 204-40-08 - STEM EXTENSION 80L X20 MM 2253082 204-70-00 - TIBIAL STEM EXT. SCREW 3000992 208-01-04 - CC FEMORAL SZ 4 3971130 208-04-73 - SCREW, OFFSET, SZ EE 4042880 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM 2830181 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM 2830212 208-07-04 - CC POSTERIOR FEM AUGMENT SZ 4, 5MM 2322728 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE 4005750 208-24-11 - CC TIBIAL INSERT SZ 4, 11MM 3778220. *ORIGINAL DESCRIPTION SUMMARY* LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH) PATIENT ID: (B)(6) LK 1ST REV REFER TO CASE-(B)(4) FOR RK 1ST REV (B)(4) FOR RK 2ND REV (B)(4) FOR LK 2ND REV. 8. PLAINTIFF WAS IMPLANTED WITH THE FOLLOWING EXACTECH DEVICE: KNEE 9. LEG IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: LEFT 10. DATE THE EXACTECH DEVICE WAS IMPLANTED: (B)(6) 2015 11. STATE IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: OH 12. DATE THE EXACTECH DEVICE WAS SURGICALLY REMOVED/REVISED: (B)(6) 2017 13. THE PLAINTIFF HAS SUFFERED FROM PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S MOBILITY AND QUALITY OF LIFE. PLAINTIFF WAS REQUIRED TO UNDERGO A REVISION SURGERY ALONG WITH THE RESULTANT PERIOD OF PAIN FOLLOWING SURGERY, RECUPERATION, REHABILITATION AND PHYSICAL THERAPY. PLAINTIFF'S ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES SUCH AS WALKING AND STANDING HAS BEEN CONSEQUENTLY LIMITED. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), 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. INITIAL EBI SURGERY UNABLE TO BE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1064362 | CC TIBIAL INSERT SZ 4, 11MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Required Intervention| H |