MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN REV CCK VE 10MM R 7-9+ EF; PROSTHESIS, KNEE

Catalog Number	42522800710
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H3- the product has been returned to zimmer biomet for investigation.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 that a patient was revised due to a fractured post on the articular surface.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
It was reported that a patient was revised due to instability and a fractured post on the articular surface.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, b7, d2, d6a, g1, g3, g6, h1, h2, h6, and h11.Corrected: h4.
Event or Problem Description
It was reported a patient was revised approximately three years and four months post implantation due to instability, inability to bear weight, and limited range of motion.The patient had an initial right total knee arthroplasty following a traumatic motor vehicle accident.Subsequently, the patient began to experience instability, inability to bear weight, and limited range of motion and underwent a revision.During the revision, the polyethylene post was fractured, the poly was upsized to 20mm, all other components were retained, and the procedure was completed without complication.At the two-week follow-up, the patient was doing well with minimal pain.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, d8, g1, g3, g6, h1, h2, h3, h6, and h11 visual examination of the returned product identified signs of implantation in the form of wear, deformation, pits, and gouges.The post of the articular surface has fractured off and was not returned.Device was submitted for further analysis.Analysis determined that the articular surface showed light pitting, wear and abrasions on the superior surface, with light gouging on the inferior surface that was likely related to explantation.Both condyles displayed pitting, scratching and gouging near the base of the post.The fracture surface appeared smooth, suggesting continued wear after the post fragment separated.The inferior side also showed plastic deformation on the locking mechanism, likely from explantation.The overall findings suggest the post fracture was possibly due to overloading, potentially worsened by repeated impingement during hyperextension.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre-revision notes: increasing instability and inability to bear weight on rle.Rom 5-100 degrees, ml instability and with standing does have 10-15 degree recurvatum.Revision notes: procedure: right tka revision and extensor mechanism reconstruction.Soft tissues debrided & tka grossly unstable.Polyethylene post was fractured.The post could not be retrieved.The wound was thoroughly irrigated.Components are well fixed.No complications.Radiographs were provided and reviewed by a health care professional, and it was determined further review would not enhance the investigation.A definitive root cause cannot be determined.This complaint is confirmed.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
No further event information available at the time of this report.

• Brand Name: PSN REV CCK VE 10MM R 7-9+ EF
• 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: 22936414
• Report Number: 0001822565-2025-03207
• Device Sequence Number: 21271130
• Product Code: JWH
• UDI-Device Identifier: 00889024555303
• UDI-Public: (01)00889024555303(17)261006(10)65232832
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/17/2026

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: Health Professional
• Device Catalogue Number: 42522800710
• Device Lot Number: 65232832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 12/23/2025; 02/13/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/23/2025; 01/16/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 113 KG