MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 16MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 150493 - oss reinforced yoke - 273020.Cp114584 - cust thin finn tib bushing - 443500.161035 - oss rs axle - 139240.150478 - oss poly lock pin - 121340.Pm100884 - small fmrl bshg set - 442970.402439 - cobalt mv bone cement 40gm b - 949020.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: 0001825034-2023-00991, 0001825034-2023-00994.
Event or Problem Description
It was reported that the patient had an initial left total knee arthroplasty on an unknown date and has undergone multiple revisions.Six months after the most recent revision, the patient underwent a revision of the axle, yoke, poly, and locking pin due to dislocation.The tibial bushing was not revised as this was a custom device and there was no backup available.There was no wear present.Attempts have been made and no further information has been provided.
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; b7; d2; d4; g1; 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.Revision operative notes confirm that patient was revised due to dislocation.Root cause cannot be determined for the dislocation.However, the incompatible combination of devices can be attributed to off label usage.Per the surgical technique, under warnings it states that 'improper selection, placement, positioning, alignment and fixation of the implant components, or absence of, or nonfunctioning quadriceps mechanism may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components'.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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
It was further reported that the patient has a surgical history of tibial tumor resections.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: pmi01195 - 67mm tibial component - unknown.Pmi01193 - custom finned femoral component - unknown.Unknown - unknown poly - unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: OSS TIBIAL POLY BEARING 16MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16894379
• Report Number: 0001825034-2023-00992
• Device Sequence Number: 6141353
• Product Code: JDI
• UDI-Device Identifier: 00880304006485
• UDI-Public: (01)00880304006485(17)241127(10)775770
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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: 11/27/2024
• Device Model Number: N/A
• Device Catalogue Number: 150412
• Device Lot Number: 775770
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 10/26/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 10/18/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• 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
• Patient Weight: 98 KG