MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH; INSTRUMENT, KNEE

Catalog Number	42557000114
Medical Device Problem Codes	Malposition of Device (2616); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Joint Laxity (4526)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Approximately two (2) years post-implantation, the patient began to experience instability.Subsequently, the patient underwent a synovectomy and revision surgery where malrotation of the tibial component was found.The tibial tray, tibial stem extension and articular surface were exchanged without reported complication.All available information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: psn tib np stm 5 deg sz d l: catalog#42532006701, lot#66434775; articular surface fixed bearing posterior stabilized (ps) left 10 mm height: catalog#42512400510, lot#65888043; all-poly patella cemented 32 mm diameter: catalog#42540200032, lot#66517832; femur cemented posterior stabilized (ps) narrow left.Size 9: catalog#42500006601, lot#64921919; palacos r + g (1x40): catalog#66022663, lot#67211312/ g2: foreign: australia.H6: proposed component code: mechanical (g04) - stem.The product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
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; g1; g3; g6; h1; h2; h3; h6; h10 the event cannot be confirmed.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.Initial operative records were provided and reviewed by a healthcare professional.A definitive root cause cannot be determined.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 STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 22106038
• Report Number: 0001822565-2025-01578
• Device Sequence Number: 20613510
• Product Code: JWH
• UDI-Device Identifier: 00889024247734
• UDI-Public: (01)00889024247734(17)340214(10)66511217
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42557000114
• Device Lot Number: 66511217
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2024
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female