UNK KNEE FEMORAL
Report
- Report Number
- 0001822565-2025-01925
- Event Type
- Injury
- Date Received
- June 13, 2025
- Date of Event
- December 9, 2024
- Report Date
- April 1, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026, TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). D2, D4, G4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. G2: FINLAND. SUGGESTED CODE (ANNEX G)- MECHANICAL (G04) - FEMUR. IRMOLA, T., REITO, A., KANGAS, J. ESKELINEN, A., NIEMELAINEN, M., MATTILA, V. M., MOILANEN (2024) ASSESSMENT OF IMPROVEMENT IN FUNCTIONAL OUTCOMES BETWEEN A NOVEL KNEE REPLACEMENT DESIGN AND CONVENTIONAL DESIGNS IN 240 PATIENTS: A RANDOMIZED CONTROLLED TRIAL. ACTA ORTHOPAEDICA 2025 96, 127¿134. HTTPS://DOI.ORG/10.2340/1745367. D10: ADDITIONAL ASSOCIATED PRODUCTS: UNK KNEE BEARING LOT# UNK. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: B4, B5, D5, G3, G6, H1, H2, H3, H6, H10, H11. D2, D4, G4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. PRODUCT HAS NOT BEEN RETURNED. NO PRODUCT EVALUATION WAS ABLE TO BE COMPLETED. REPORTED EVENT IS NOT RELATED TO DEVICE THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. ARTHROFIBROSIS IS DEFINED AS THE DEVELOPMENT OF FIBROUS SCAR TISSUE WITHIN OR SURROUNDING A JOINT. ARTHROFIBROSIS IS A KNOWN POSTOPERATIVE PROCEDURE RELATED COMPLICATION THAT CAN OCCUR FROM SURGICAL IMPLANTATION OF NEW JOINT REPLACEMENT AS WELL AS FROM PREVIOUS INJURIES OR SURGICAL PROCEDURES. SCAR TISSUE FORMATION IS A NORMAL HEALING RESPONSE; HOWEVER, THE BUILDUP OF SUCH CAN RESULT IN PAIN, STIFFNESS, LIMITED RANGE OF MOTION, AND DIFFICULTY PROPERLY AMBULATING. IF EXCESS SCAR TISSUE DEVELOPS, CONSERVATIVE MEASURES SUCH AS EXERCISES OR PHYSICAL THERAPY WOULD BE ATTEMPTED FIRST. IF THESE ATTEMPTS FAIL, SURGICAL INTERVENTION SUCH AS MANIPULATION UNDER ANESTHESIA, ARTHROSCOPIC ARTHROLYSIS, OR OPEN ARTHROTOMY WOULD BECOME NECESSARY TO REMOVE THE FIBROUS TISSUE AND RESTORE JOINT FUNCTION. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THROUGH A JOURNAL ARTICLE THAT 2 PATIENTS IN THE GROUP REQUIRED MANIPULATION UNDER ANESTHESIA POST TKA. NO ADDITIONAL INFORMATION IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342072 | UNK KNEE FEMORAL | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | SEE H11 NARRATIVE |