MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF R 11MM 8-11/GH; PROSTHESIS, KNEE

Catalog Number	42522100911
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	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42522100911 - psn mc ve asf r 11mm 8-11/gh - 65336417.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient had an initial right total knee arthroplasty.Subsequently, at a follow up appointment approximately 6 weeks post-op, the patient had a flexion contracture with a range of motion of 21-93 degrees and underwent a manipulation under anesthesia.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated : b3; b4; b5; d2; e1; g1; g3; g6; h1; h2; h10.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that a manipulation under anesthesia was performed with range of motion postoperatively achieved at 0-130° with no complications.Attempts have been made and all available information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d7; g1; g3; g6; h1; h2; h3; h6; h10.The event is confirmed.As the devices remain implanted, no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent an initial knee surgery without complications.No complications were noted at one month post-op.At 3 months post-op, patient had rom 21-93 degrees- flexion contracture, flexion 56 and extenuation 12.Patient is full weight bearing, no swelling, tenderness, or warmth, wound clean and dry, neurovascular intact.X-ray shows implants in good position.Patient is doing well, ambulates with a cane, attending pt x2 a week, however, patient has not made significant progress since last follow up and mua is scheduled.Mua notes noted no complications, preop rom: 10-80°, postop rom: 0-130°.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusion or information, a supplemental report will be filed accordingly, zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA MC VE ASF R 11MM 8-11/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: 23906080
• Report Number: 3007963827-2025-00540
• Device Sequence Number: 13268087
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42522100911
• Device Lot Number: 65336417
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 12/07/2025; 05/18/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/21/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 220 LB