MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING (CPS) RIGHT 12 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522600712
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580); Radiolucent Lines (4848); Crepitus (4893)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: femur cemented posterior stabilized (ps) standard right size 7: catalog#42500606202, lot#65625058; tibia cemented 5 degree stemmed right size e: catalog#42532007102, lot#65561390; stem extension tapered cemented 14mm diameter +30mm length: catalog#42557000114, lot#65845249.G2: foreign - event occurred in south africa.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 3500a will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery due to unknown complications.Due diligence is in progress for this event; to date no additional information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b3; b4; b5; d6b; e1; g2; g3; h2; h6; h10; h11.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Patient continued to experience pain, swelling/edema, decreased range of motion, grinding, and instability.Diagnostic imaging revealed no evidence of lucency.Approximately one (1) year post-implantation, patient received a cortisone injection to relieve symptoms and one month following the injection underwent an iliotibial band lengthening procedure but symptoms continued.Subsequently, one (1) year and eight (8) months post-implantation, the patient underwent revision surgery.During the revision it was noted that the screw between the stem and tibia plate was found with the head not below the surface of the tibia plate.All components were revised without reported complication.All available information has been provided.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Postoperatively, the patient continued to experience persistent pain, swelling/edema, decreased range of motion, grinding, and instability.Approximately one (1) year post-implantation, patient received a cortisone injection to relieve symptoms and one month following the injection underwent an iliotibial band lengthening procedure with subsequent hematoma drainage a few days later but symptoms continued.One (1) year and three (3) months post-implantation, a surgical repair of a torn tendon was performed.The patient consulted a new orthopedic surgeon that identified radiolucency of the tibial component on diagnostic images.Subsequently, one (1) year and eight (8) months post-implantation, the patient underwent revision surgery.During the revision it was noted that the screw between the stem and tibia plate was found with the head not below the surface of the tibia plate.All components were revised without reported complication.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; b7; e1; g3; h2; h3; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.Legal documents were provided and reviewed: state that the patient underwent an initial right total knee arthroplasty.The available information indicates there were no reported intraoperative complications, and postoperative x-rays reportedly showed no lucency.Postoperatively, the patient experienced persistent pain, swelling, reduced range of motion, grinding, and instability.The patient then obtained a second opinion, at which time radiolucency of the tibial component was reportedly observed on x-ray.A right total knee revision was then performed on during which it was reportedly noted that the screw between the stem and tibial implants was not tightened and that the head of the screw within the tibial plate was not below the surface.The legal allegations further state that the screws were not properly tightened at the initial surgery and that postoperative x-rays were not properly assessed.No additional medical records were provided beyond the legal documentation.Root cause was unable to be determined.Reported event was unable to be confirmed.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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING (CPS) RIGHT 12 MM HEIGHT
• 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: 24447140
• Report Number: 3007963827-2026-00078
• Device Sequence Number: 13314997
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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: 42522600712
• Device Lot Number: 65546350
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 05/13/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/17/2026; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male