MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C LM PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Tissue Breakdown (2681); Metal Related Pathology (4530)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown oxford femoral; item#unknown; lot#unknown, unknown oxford bearing; item#unknown; lot#unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00098, 3002806535 - 2023 - 00099.Part and lot number unknown.
Event or Problem Description
It was reported that the patient underwent revision surgery due to an implant fracture, approximately 9 years post-implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: oxf twin-peg cmntd fem md pma; item#161469; lot#505080.Oxf anat brg lt md size 3 pma; item#159547; lot#2965903.Palacos r 1x40 single; item#00-1112-140-01; lot#76384339.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of manufacturing records cannot be performed without product identification.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.Review of op record stated that patient presented with severe pain for one week and that the preop diagnosis identified a failed orthopedic left partial knee implant that required replacement.Supporting x-ray showed a fracture of the femoral component and polyethylene component was worn and fractured which contradicted x-ray findings.Femoral component removed with minimal bone loss, noted cavitary defect from poly wear to the medial condyle, diseased necrotic or fibrotic tissue removed with radical synovectomy to whole knee.Previous incision utilized with significant scar tissue and metallosis encountered.Tibia component excised and noted some cavitary defect from poly wear.The surgery was completed without complication and full range of movement & stability was experienced throughout.Post op x-ray confirmed that tka was satisfactory, long stem tibial component is noted.Subcutaneous emphysema was present however, this was deemed to be normal immediately post op.With the available information, a definitive root cause cannot be determined.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.
Event or Problem Description
It was reported initial left unicompartmental arthroplasty.Subsequently revised due to severe pain for one week and fractured implant.During the revision noted poly fracture and wear, scar tissue, bone defect from poly wear, tissue damage, and metallosis.All components were exchanged, and patella implanted without complications.Attempts have been made and all additional information received has been included in this report.

• Brand Name: OXF UNI TIB TRAY SZ C LM PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16681660
• Report Number: 3002806535-2023-00100
• Device Sequence Number: 15256326
• Product Code: NRA
• UDI-Device Identifier: 05019279388882
• UDI-Public: (01)05019279388882(17)231003(10)754150
• Combination Product (Y/N): N
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/03/2023
• Device Model Number: N/A
• Device Catalogue Number: 154722
• Device Lot Number: 754150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male