MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED (PS) STANDARD RIGHT SIZE 6; PROSTHESIS, KNEE

Catalog Number	42500606002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Bursitis (4832)
Date of Event	02/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study that a patient underwent an initial total knee arthroplasty.Approximately four (4) years post-implantation, the patient experienced a sudden onset of stiffness, pain, and bursitis with no apparent cause.The patient was treated with a cortisone injection and the symptoms were reported to have resolved fourteen (14) months post-onset.Due diligence is in progress for this event; to date no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: tibia cemented 5 degree stemmed right size d: catalog #42532006702, lot #63474954; articular surface fixed bearing posterior stabilized (ps) right 10 mm height: catalog #42521400510, lot #62296922.G2: foreign: netherlands.H6: proposed component code: mechanical (g04) - femur.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; e1; e2; e3; g2; g3; h1; h2; h3; h6; h10; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional and it was determined further review would not enhance the investigation.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.
Event or Problem Description
It was reported that two months post-resolution of previous incident patient began to again experience discomfort with the implanted prosthesis.Steroid medication was prescribed and no additional intervention was required.All available information has been provided.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following section has been corrected: h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional and it was determined further review would not enhance the investigation.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 FEMUR CEMENTED (PS) STANDARD RIGHT SIZE 6
• 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 BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22871995
• Report Number: 3007963827-2025-00325
• Device Sequence Number: 16024909
• Product Code: JWH
• UDI-Device Identifier: 00889024229204
• UDI-Public: (01)00889024229204(17)251231(10)63253075
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 42500606002
• Device Lot Number: 63253075
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 11/18/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/08/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2016
• 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
• Patient Sex: Unknown