MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT OPTION SIZE F LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Burning Sensation (2146); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Tissue Breakdown (2681); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty due to a work related injury resulting in bilateral knee posttraumatic arthritis.Since the initial procedure, the patient has complaint of ongoing and increasing pain, swelling, instability, limp, and heat in the joint.The patient has been recommended for revision surgery as recent x-rays suggest loosening.Subsequently, the patient was revised approximately 7 years post-op due to aseptic loosening.During the revision, the surgeon noted osteolysis to the tibia and femur, a large defect secondary to chronic loosening, and fibrous membrane formation.The tibia, femur, and articulating surface were exchanged with competitor products without complications.The patella remained implanted.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00598005701 - stemmed tibial component precoat size 7 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 63283972.00596205110 - articular surface use with lps/lps-flex 51 or 52 suffix femorals size ef 10 mm height - 62994139.00111314001 - palacos rg 1x40 single - 84344539.00111314001 - palacos rg 1x40 single - 84344539.00597206538 - all poly patella standard cemented size 38 mm diameter 9.5 mm thickness - 62939856.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00316, 0001822565-2023-00378, 0001822565-2023-03753, 0001822565-2023-03756.
Additional Manufacturer Narrative
His follow-up report is being submitted to relay additional information.H6 : suggested component code: mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: boggy effusion or synovitis, evolving periprosthetic lucency surrounding the tibial stem, consistent with loosening, potential crack within the tibial cement, cortical defect/osteolysis noted in the medial femoral condyle, potential subsidence of the tibial stem, osteolysis of the femoral condyle, large central cavitary defect in the tibial metaphysis, fibrous membrane formation.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.G2 : user facility report : mw5157058.Upon receipt of additional information, it was determined that mw5157058 is linked to (b)(4).Please note a previous user facility report #mw5114429 has already been received for this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT OPTION SIZE F LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18409385
• Report Number: 3007963827-2023-00356
• Device Sequence Number: 8766917
• Product Code: JWH
• UDI-Device Identifier: 00889024001138
• UDI-Public: (01)00889024001138(17)260630(10)63404818
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

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: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00596401651
• Device Lot Number: 63404818
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 05/16/2024; 08/07/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 05/17/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 101 KG