MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS REINFORCED YOKE; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure eight months post implantation due to pain and tibial dislocation in knee.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).Medical product: oss rs 20mm ls tibial bearing catalog # 161098 lot # 762730.Oss rs poly fem bushings set/2 catalog # 161034 lot # 462810.Oss rs axle catalog # 161035 lot # 006970.Oss poly lock pin catalog # 150478 lot # 530370.Oss poly tibial bushing catalog # 150476 lot # 479930.Report source: france.Customer has indicated that the product will not be returned because product location is unknown.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 filled to relay additional information, which was unknown at the time of the initial medwatch.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
Event or Problem Description
It was reported patient underwent a revision procedure eight months post implantation due to pain and tibial dislocation in knee.During the revision, it was found that the wings of the yoke were ruptured, making the hinge unstable.The hinge was exchanged from the femoral axis to the tibial pin without complication.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated.Visual evaluation of the returned device shows signs of repeated use and both of the fin features have fractured off the fins were not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates an initial left tka was performed on (b)(6) 2018, with subsequent revisions on (b)(6) 2021 and (b)(6) 2022 , and an aspiration for infection (b)(6) 2022.A third revision occurred on (b)(6) 2022 due to pain and dislocation.During the revision it had found the yoke wings had ruptured, causing the hinge to be unstable.The hinge assembly and tibial bearing were explanted and replaced with new oss devices, no complications noted.If any further information is found which would change or alter any conclusions or information, a supplemental 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: OSS REINFORCED YOKE
• 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: 15734438
• Report Number: 0001825034-2022-02493
• Device Sequence Number: 6321997
• Product Code: JDI
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)310322(10)109010
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 03/07/2023

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 Model Number: N/A
• Device Catalogue Number: 150493
• Device Lot Number: 109010
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 01/23/2023; 03/01/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/04/2023; 02/01/2023; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 80 KG