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 Code	Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown , unknown articular surface , unknown 00588000310 , tibial full block augment precoat size 3 10 mm thickness , 64702498.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565-2021-03115.
Event or Problem Description
It was reported that the patient underwent an initial rhk knee procedure.Approximately 5 months later, the patient went to the physiotherapist and felt a 'crack' in his knee.The knee was totally unstable with the hinge still in the tibial component but not more in the intercondylar ring of the femur.Subsequently, the hinge and articular surface were revised.Attempts have been made and no further information has been provided.
Event or Problem Description
The femoral component remains implanted in the patient, however, the hinge kit that was a part of this item was revised and will be returned.There was no surgical delay.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
D10: 00588005014 - articular surface with hinge post extension screw enclosed do not discard size e 14 mm height - 64649676.00588000310 - tibial full block augment precoat size 3 10 mm thickness - 64702498.This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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; h3; h6 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.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: disassociation of the constraining hinge and knee subluxation; initial fit and alignment were maintained, bone quality is osteopenic; no evidence of implant loosening and no fractures are identified.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.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12698619
• Report Number: 0001822565-2021-03114
• Device Sequence Number: 16513942
• Product Code: JWH
• UDI-Device Identifier: 00889024199156
• UDI-Public: (01)00889024199156(17)251029(10)64731740
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2022

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: 10/29/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588001502
• Device Lot Number: 64731740
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 11/07/2021; 02/16/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/10/2021; 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male