MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN MC VE ASF R 10MM 12/GH; PROSTHESIS, KNEE

Catalog Number	42522101010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient was revised approximately 9.5 months post implantation to provide improved access to posterior knee for release.The sales rep noted just a posterior capsule release.Range of motion in the knee extension was limited.Once the release was performed, the range of motion restriction in extension was no longer present.The same size bearing was inserted once the release was performed.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11 the reported event could not be confirmed.Product has not been returned.No product evaluation was able to be completed.The device history record was not reviewed.A posterior capsule release is required when soft tissue such as scarring or ligament tissue impedes full range of motion resulting in a flexion contracture or instability.While conservative measures such as exercises or physical therapy would be attempted first, if these attempts fail, surgical intervention such as arthroscopic arthrolysis or open arthrotomy would become necessary to release the constricting tissue and restore joint function.As the complaint indicates, the release resolved the complication, and a similar device was placed without further complications.Root cause of the reported event is not device related.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PSN MC VE ASF R 10MM 12/GH
• Common Device Name: PROSTHESIS, KNEE
• 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: 22883881
• Report Number: 3007963827-2025-00327
• Device Sequence Number: 9604737
• Product Code: MBH
• UDI-Device Identifier: 00889024468573
• UDI-Public: (01)00889024468573(17)290129(10)66382404
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42522101010
• Device Lot Number: 66382404
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown