MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXTENSION TAPERED CEMENTED; PROSTHESIS, KNEE

Catalog Number	42557000114
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial knee surgery, post-op x-rays were taken and revealed that the nubby stem was disengaged from the tibial tray.The surgical technique was utilized during surgery.The surgeon is not planning to revise the patient at this time.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42532007502 - psn tib stm 5 deg sz f r - (b)(6).42506006802 - posterior stabilized right size 10 pps narrow femur - (b)(6).42522400813 - articular surface fixed bearing posterior stabilized (ps) right 13 mm height - (b)(6).H6: mechanical (g04) - stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that no revision is planned at this time.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: a1; a2; a3a; b4; b5; d2; g1; g3; g6; h1; h2; h10.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h4; h6; h10.The following section was corrected: b2.The reported event was confirmed by review of radiographs.No product was returned or pictures provided; visual and dimensional evaluations could not be performed radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap and lateral view of the right knee shows changes of knee arthroplasty without patellar resurfacing and cemented tibial tray.There is malalignment at the modular junction for the tibial tray/stem compatible with component disassembly.Left knee arthroplasty with disassembly of the tibial component at the modular junction for the tray and distal stem.The device history record was reviewed and no discrepancies relevant to the reported event were found.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA STEM EXTENSION TAPERED CEMENTED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 23804273
• Report Number: 0001822565-2025-04502
• Device Sequence Number: 18047853
• Product Code: JWH
• UDI-Device Identifier: 00889024247734
• UDI-Public: (01)00889024247734(17)350901(10)67480492
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42557000114
• Device Lot Number: 67480492
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 04/28/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/05/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Female