OXFORD ANAT BRG LT MD SIZE 3 PMA
Report
- Report Number
- 3002806535-2025-00177
- Event Type
- Injury
- Date Received
- April 30, 2025
- Date of Event
- February 17, 2025
- Report Date
- July 24, 2025
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- P010014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10 ASSOCIATED MEDICAL DEVICES: OXF TWIN-PEG CMNTD FEM MD PMA; ITEM # 161469; LOT # 2870923. OXF UNI TIB TRAY SZ C LM PMA; ITEM # 154722; LOT # 2800091. COBALT G-HV BONE CEMENT 40G; ITEM # 402283; LOT # 682710. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. THE RETURNED PRODUCT WAS VISUALLY ASSESSED, AND THE BEARING EXHIBITS EVIDENCE OF ADVANCED WEAR, INCLUDING SURFACE FEATURES SUCH AS PITS AND GOUGES. THE OBSERVED CONDITION IS CONSISTENT WITH THE REPORTED FINDINGS, INCLUDING THE PRESENCE OF A FRACTURE. THE ITEM IS SEPARATED INTO TWO PIECES: A LARGE MAIN PIECE, AND A SMALLER FRAGMENT SEPARATED FROM IT COMPRISED OF MOST OF THE POSTERIOR SIDE, EXCEPT FOR A SECTION TO THE MEDIAL SIDE. THE BEARING WAS SUBSEQUENTLY SUBMITTED FOR FURTHER ANALYSIS UNDER MAGNIFICATION. THE ARTICULATION SURFACE SHOWS POTENTIAL EVIDENCE OF POSSIBLE DELAMINATION AND/OR CRACKING. THE FRACTURE SURFACES ON THE MAIN PIECE SHOWS POSSIBLE EVIDENCE OF SUBSURFACE WHITENING, POTENTIALLY AN INDICATION OF OXIDATION. THE FRAGMENT ALSO SHOWS EVIDENCE OF POSSIBLE FATIGUE STRIATIONS NEAR THE POSTERIOR SIDE WITHIN THE FRACTURE SURFACE, WHICH POSSIBLY INDICATES THAT THERE WAS A PROGRESSION OF THE FRACTURE AFTER THE INITIAL CRACKING OR DELAMINATION BEFORE THE FRAGMENT WAS COMPLETELY SEPARATED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THAT 20 DAYS BEFORE THE REVISION SURGERY, THE PATIENT HAD A FOLLOW UP WHERE THE FOLLOWING WAS NOTED: THE PATIENT PRESENTED WITH MECHANICAL LOOSENING OF THE KNEE JOINT PROSTHESIS AND PAIN. IMAGING SUGGESTED POLYETHYLENE FAILURE WITH PRESERVED LATERAL JOINT SPACE AND NO OBVIOUS FRACTURE. IT IS NOTED TO PROCEED WITH THE REVISION. FURTHER TO THE FOLLOW-UP, A REVISION SURGERY WAS THEN PERFORMED. INTRAOPERATIVE FINDINGS REVEALED THAT THE OXFORD POLYETHYLENE COMPONENT ON THE MEDIAL FEMUR AND TIBIA WAS BROKEN, WITH GROOVING PRESENT ON BOTH THE FEMORAL AND TIBIAL METAL SURFACES. ON THE LATERAL FEMUR AND TIBIA, THERE WAS EVIDENCE OF ADVANCING ARTHRITIS, AND A LATERAL CYST MEASURING APPROXIMATELY 8¿9 MM WAS TREATED WITH BONE GRAFTING. ADDITIONALLY, THE ANTERIOR CRUCIATE LIGAMENT (ACL) WAS FOUND TO BE ATTENUATED AND DEFICIENT. NO INTRAOPERATIVE COMPLICATIONS OR ADVERSE EVENTS WERE ENCOUNTERED DURING THE PROCEDURE. THE PATIENT HAD A BMI OF 35 AND WEIGHT OF 225 POUNDS. THE IMPLANT HAD BEEN IN VIVO FOR OVER 12 YEARS. BASED ON THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT APPEARS THAT THE FRAGMENT SEPARATION WAS LIKELY THE RESULT OF A FATIGUE FRACTURE, POTENTIALLY INITIATED BY OXIDATION-RELATED DEGRADATION THAT LED TO DELAMINATION OF THE MATERIAL. THIS CONDITION MAY ALSO HAVE BEEN A RESULT OF PROLONGED MECHANICAL LOADING AFFECTED BY PATIENT FACTORS (YOUNGER AGE AT TIME OF IMPLANT, AS WELL AS PATIENT WEIGHT/BMI (225 POUNDS, BMI 35)), AND A LONG PERIOD OF IMPLANTATION PRIOR TO REVISION (12+ YEARS IN VIVO). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, DEVELOPED CLICKING, POPPING, STIFFNESS AND UPON GETTING UP OUT OF A CHAIR, HEARD A LOUD POP. AT A FOLLOW-UP VISIT TO THE HOSPITAL, APPROXIMATELY TWELVE YEARS AND ONE MONTH POST IMPLANTATION, THE PATIENT REPORTED PAIN AND THROUGH EXAM AND RADIOGRAPHIC IMAGING IDENTIFIED MECHANICAL LOOSENING AND FAILURE OF THE BEARING. APPROXIMATELY TWELVE YEARS AND TWO MONTHS POST INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION TO A TOTAL KNEE ARTHROPLASTY AND DURING THE PROCEDURE IDENTIFIED A FRACTURE OF THE BEARING AND GROOVING OF THE FEMORAL AND TIBIAL COMPONENTS. ALL IMPLANTS WERE REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1463717 | OXFORD ANAT BRG LT MD SIZE 3 PMA | KNEE PROSTHESIS | NRA | BIOMET UK LTD. | 2807244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| H | SEE H11 NARRATIVE. |