MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Hyperextension (4523); Swelling/ Edema (4577)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial knee arthroplasty.Approximately 9 months later, the patient was revised as their knee was in 15 degree recurvatum.A new femoral component was implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01852.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h6; h10.H6: 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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no significant radiolucency, no metallic foreign body, large joint effusion, prepatellar edema.Overall fit and alignment is appropriate, osteopenia is present, no signs of loosening or wear, and no x-ray evidence of malfunction.A definitive root cause could not 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
Upon receiving additional information, it was reported that the patient was revised due to pain and instability.
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: h6: proposed component (annex g) code is mechanical (g04) - femur.Visual examination of the returned articular surface identified signs of being implanted (nicked/ gouged) and worn.A hex feature is fractured off in the hinge post extension component which was report by the surgeon during the revision surgery.Visual examination of the returned femoral component identified signs of being implanted (nicked / gouged) and foreign material on the implant.The hinge post component item # 00588011580 was cut.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 available records identified the following: no significant radiolucency, no metallic foreign body, large joint effusion, prepatellar edema, overall fit and alignment is appropriate, osteopenia is present, no signs of loosening or wear, no x-ray evidence of malfunction 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.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT
• 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: 14754780
• Report Number: 0001822565-2022-01854
• Device Sequence Number: 6022778
• Product Code: JWH
• UDI-Device Identifier: 00889024199156
• UDI-Public: (01)00889024199156(17)251129(10)64731746
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 11/27/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588001502
• Device Lot Number: 64731746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/30/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 11/22/2023
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/08/2022; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 97 KG