MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN ASF PS 14MM VE R 10-12 GH; PROSTHESIS, KNEE

Catalog Number	42522401014
Medical Device Problem Code	Pitted (1460)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a washout and polyethylene insert exchange approximately 2 days post-implantation following a fall with wound dehiscence.A washout procedure with polyethylene insert exchange was performed.Upon removal, the polyethylene insert was observed to have pitting on the medial and lateral condyles.Attempts have been made and no further information has been provided.
Event or Problem Description
No additional information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h6.The following section was corrected: h4.The reported event was confirmed via product return.Visual inspection of the returned bearing exhibited signs of use and pitting on the surface.Device also showed some damage on the dovetail, likely caused during explantation.Analysis of the returned device indicates that the observed damage is unlikely to have developed within 48 hours of implantation; however, third-body debris may account for the observed pitting.Based on further analysis, the observed pitting appears to have occurred after the machining process and does not appear to be attributable to the manufacturing process.The findings further suggest that the pits may be consistent with impact-related damage, potentially associated with a fall.Review of the device history records identified no related deviations or anomalies during manufacturing.No medical records were provided.It was reported that the patient fell, however the cause of the fall is unknown.The root cause for the wound dehiscence was determined to be unrelated to the device.The root cause for wear cannot be determined.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: PSN ASF PS 14MM VE R 10-12 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23574353
• Report Number: 3007963827-2025-00464
• Device Sequence Number: 13261999
• Product Code: MBH
• UDI-Device Identifier: 00889024244030
• UDI-Public: (01)00889024244030(17)271019(10)65546205
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 04/07/2026

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: Lay User/Patient
• Device Catalogue Number: 42522401014
• Device Lot Number: 65546205
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2025
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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; Hospitalization
• Patient Sex: Male