MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENTAL ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure two years post implantation due to disassociated locking mechanism.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: stem collar 30 mm o.D.For use with 16 mm or smaller diameter segmental stems catalog # 00585204030 lot # 65214976.Distal femoral xt component size b right use with polyethylene insert xt size b use with xt only for cemented use only in the u.S.A.Catalog # 00585004202 lot # 65306764.Size 3 precoat non-modular cemented tibial component catalog # 00588000302 lot # 65245238.Tibial central cone size x-small catalog # 42545000510 lot # 64800264.Polyethylene insert xt size b use with distal femoral xt size b use with xt only catalog # 00585001296 lot # 65244772.Fluted stem extension straight precoat for cemented use only 14 mm diameter 130 mm length catalog # 00585205014 lot # 65232179.Reported event was confirmed by review of x-rays provided.Device was 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.X-ray review indicates there is tibial locking mechanism appears to be loose with set screw noted posterior and medial to the knee joint.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
It was reported patient had disassociated locking mechanism post implantation.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h11.The additional information received does not change the previous investigation.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: SEGMENTAL ARTICULAR SURFACE
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19666631
• Report Number: 0001822565-2024-02226
• Device Sequence Number: 6904841
• Product Code: KRO
• UDI-Device Identifier: 00889024195714
• UDI-Public: (01)00889024195714(17)290519(10)65081475
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 01/13/2025

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: 00585002020
• Device Lot Number: 65081475
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 01/10/2025
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/06/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Female