MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a conversion to a rotating hinged knee.Subsequently, the patient has experienced hyperextension and is being scheduled for a revision, on an unknown date.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information or product is available, we are unable to provide further information.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ref 00588005017, lot 64083937, art surface - nexgen rotating hinge knee ¿ size e 17mm.Ref 00598801013, lot 64231567, stem extension- nexgen ¿ straight.Ref 00598801215, lot 64196846, stem extension ¿ nexgen ¿ straight.Ref 00588001502, lot 11023955, femoral ¿ nexgen rotating hinge knee ¿ size e.Ref 00588005014, lot 64256366, art surface ¿ nexgen rot.Ating hinge knee- size e 14mm.Ref 00588000400, lot 64118706, tibial- nexgen rotating hinge knee ¿ size 4.Ref 00588000410, lot 64109647, tibial augment ¿ nexgen ¿ size 4 10mm thickness.Ref 3204, lot 2961147, stühmer/weber medullary plug without drain, pe, cemented 4/16.Ref 3204, lot 2974514, stühmer/weber medullary plug without drain, pe, cemented 4/16.Ref 66017747, lot 90624788, palacos r+g 2x40.Ref 66017772, lot 91810019, palacos r+g 1x60.Report source: foreign country: germany.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.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: 0001822565 - 2022 - 02307.
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.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: valgus malposition after implantation of coupled knee joint one year ago and persistent ankle and knee joint complaints; no intra-op complications/events.Root cause was unable to 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: ARTICULAR SURFACE WITH HINGE POST
• 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: 15189340
• Report Number: 0001822565-2022-02308
• Device Sequence Number: 12265442
• Product Code: JWH
• UDI-Device Identifier: 00889024199385
• UDI-Public: (01)00889024199385(17)230731(10)64083937
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00588005017
• Device Lot Number: 64083937
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male