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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure four years post implantation due to implant fracture.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: oss reinforced yoke catalog # 150493 lot # 083330.Oss poly lock pin catalog # 150478 lot # 025620.Oss rs poly fem bushings set/2 catalog # 161034 lot # 383070.Oss rs axle catalog # 161035 lot # 562660.Oss cmntd prox tib stem 11x150 catalog # 150445 lot # 892110.Oss poly tibial bushing catalog # 150476 lot # 131560.Palacos mv+g catalog # 66031993 lot # 88154780.Medullary plug with drain 3 catalog # 3223 lot # 2929712.Medullary plug with drain 4 catalog # 3224 lot # 2889100.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2022-01530.
Event or Problem Description
It was reported patient underwent a revision procedure four years post implantation due to pain and implant fracture.Attempts to obtain additional information have been made; however, no more is available at this time.
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 submitted to relay additional information.Reported event was confirmed by review of photograph provided.Visual evaluation of the device photograph confirms that the device fins are fractured and photograph of bearing showed wear consistent with usage.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause cannot be determined.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: type of investigation - device not returned is n/a which was reported on initial report.Visual evaluation of the returned device shows wear consistent with usage.Additional information does not affect the root cause.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.

• Brand Name: OSS RS 16MM LS TIBIAL BEARING
• 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: 14874132
• Report Number: 0001825034-2022-01533
• Device Sequence Number: 5224382
• Product Code: KRO
• UDI-Device Identifier: 00880304481121
• UDI-Public: (01)00880304481121(17)220325(10)456830
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2023
• 2 Devices were Involved in the Event: 1 2

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: 03/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 161096
• Device Lot Number: 456830
• 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: 06/21/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 08/22/2022; 01/30/2023
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/26/2022; 08/26/2022; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2017
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 78 KG