MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEM CR CMT CCR STD SZ 11 R; PROSTHESIS, KNEE

Catalog Number	42502607002
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).H6: mechanical (g04) - femur.D10: 42502607002 - psn fem cr cmt ccr std sz 11 r - 66528580.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; h3; 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.
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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA FEM CR CMT CCR STD SZ 11 R
• 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: 23906082
• Report Number: 3007963827-2025-00539
• Device Sequence Number: 13268088
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• 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: 42502607002
• Device Lot Number: 66528580
• 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: 01/07/2026; 05/18/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/21/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 220 LB