MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS CEMENTED IM STEM 11MMX90MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a right knee revision approximately three years post-implantation due to implant fracture.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D4: due to the initial invoice being unclear, the fractured stem is either this part/lot reported above or: oss cemented im stem 9mmx90mm part#: 150358 lot#: 146240.Udi: (b)(4).Manufacture date: 8/14/2018.Expiration date: 8/14/2028.D10 medical devices: oss 9cm prox tib mod cocr catalog#: cp113462 lot#: 784750.Oss poly lock pin catalog#: 150478 lot#: 807210.Oss tibial poly bearing 12mm catalog#: 150410 lot#: 727570.Oss 3cm resurfacing femoral rt catalog#: 150350 lot#: 048870.Oss poly femoral bushings catalog#: 150477 lot#: 677140.Oss poly tibial bushing catalog#: 150476 lot#: 807150.Oss reinforced yoke catalog#: 150493 lot#: 171040.Oss axle catalog#: 150480 lot#: 170340.Intramedullary plug 11-13mm catalog#: 130611 lot#: 371350.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was kept by the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02328 and 0001825034-2024-00301.Proposed component code: mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information received from the customer.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.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 CEMENTED IM STEM 11MMX90MM
• 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: 17895778
• Report Number: 0001825034-2023-02328
• Device Sequence Number: 6979922
• Product Code: KRO
• UDI-Device Identifier: 00880304238886
• UDI-Public: (01)00880304238886(17)290529(10)372770
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 150360
• Device Lot Number: 372770
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 21 YR
• Patient Sex: Male