MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. 0° SPIKED KEEL RIGHT SIZE G OSSEOTI TIBIA; KNEE PROSTHESIS

Catalog Number	42535007902
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: psn mc ve asf r 11mm 8-11/gh, #item 42522100911, #lot 67247936, therapy date: (b)(6) 2026.G2: foreign report source japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that when using persona osseoti 0-degree tibial component, the articular surface did not fit.There was no patient impact, surgical technique utilized.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 0° SPIKED KEEL RIGHT SIZE G OSSEOTI TIBIA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24321621
• Report Number: 3007963827-2026-00056
• Device Sequence Number: 13272118
• Product Code: JWH
• UDI-Device Identifier: 00889024631977
• UDI-Public: (01)00889024631977(17)340905(10)66704977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 06/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42535007902
• Device Lot Number: 66704977
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown