MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED; 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	09/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee procedure and approximately 1 year later, was revised due to instability.The patient was revised to a new system and the surgeon noted that the implants were well fixed.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42504605801 - femur cemented standard left size 5 - 64998914, 42542006402 - tibia fixed cemented right size c stem extension use required - 64960938, 42556605805 - femoral distal augment cemented size 5, 5+ 5 mm thickness - 64988990, 42556605810 - femoral distal augment cemented size 5, 5+ 10 mm thickness - 64863054, 42560113512 - stem extension straight splined uncemented 12 mm diameter +135 mm length - 64963305, 42555803405 - tibial augment cemented half block right medial size cd 5 mm thickness - 65042379, 42555803205 - tibial augment cemented half block right lateral size cd 5 mm thickness - 65314944, 42560313512 - stem extension 3mm offset splined uncemented 12 mm diameter +135 mm length - 65042683.66022663 - palacos r + g (1x40) - 62501128.66022663 - palacos r + g (1x40) - 62501128.66022663 - palacos r + g (1x40) - 62221123.G2 : foreign country : australia.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: 0001822565-2023-02850.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d10: 42504605802 - femur cemented standard right size 5 - 64998914 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: 0001822565-2024-00176.
Event or Problem Description
No further event information available at the time of this report.
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.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.Medical records were not provided.A definitive root cause cannot 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 FIXED BEARING POSTERIOR STABILIZED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17942148
• Report Number: 3007963827-2023-00286
• Device Sequence Number: 12455854
• Product Code: MBH
• UDI-Device Identifier: 00889024562530
• UDI-Public: (01)00889024562530(17)250830(10)64667021
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121771
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 42522400418
• Device Lot Number: 64667021
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 01/26/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/18/2024; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Female