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

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Burning Sensation (2146); Osteolysis (2377); Ambulation Difficulties (2544); Tissue Breakdown (2681); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 10/11/2023

Event Type  Injury  

Event 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.

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.

• Brand Name: FEMORAL COMPONENT OPTION SIZE F LEFT
• Type of Device: 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
• MDR Text Key: 331498249
• Report Number: 3007963827-2023-00356
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024001138
• UDI-Public: (01)00889024001138(17)260630(10)63404818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 101 KG