MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LEFT SIZE C CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number	5880-13-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown tibial component: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for evaluation as it has been discarded by the hospital.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Subsequently, three years post-implantation, the patient began to experience pain and dysfunction of the knee prosthesis.It was determined that the plastic bushing of the femoral component had fractured and the patient underwent revision surgery to replace the component without complication.It was reported that no further information is available.
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.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 visual examination of the provided pictures identified the poly box insert as fractured.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the medical records identified: a broken hinge bushing resulting in malalignment of the tibiofemoral implant.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 at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: size 3 precoat non-modular cemented tibial component: catalog#: 00588000302, lot#: 64146495; 23mm height size c articular surface with hinge post extension: catalog#: 00588003023, lot#: 63233913; 14mm diameter 100mm length offset stem extension: catalog#: 00598802014, lot#: 64004016; prc agmt block dist sz c 5mm: catalog#: 00599003310, lot#: 62963051; prc agmt block dist sz c 5mm: catalog#: 00599003310, lot#: 63088994.The investigation is in progress.Once the investigation is complete, a follow-up mdr will be submitted.

• Brand Name: LEFT SIZE C CEMENTED OPTION FEMORAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16987398
• Report Number: 0001822565-2023-01394
• Device Sequence Number: 6693689
• Product Code: JWH
• UDI-Device Identifier: 00889024199101
• UDI-Public: (01)00889024199101(17)230131(10)11023197
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2023

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 5880-13-01
• Device Catalogue Number: 00588001301
• Device Lot Number: 11023197
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 05/22/2023; 08/23/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/01/2023; 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG