MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 14MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Ambulation or Postural Difficulties (2544)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision cemented tibial component left size f catalog #: 42542007501 lot #: 65314913, persona cemented half block tibial augment left medial size ef 10mm catalog #: 42555805310 lot #: 65324396, persona cemented half block tibial augment left lateral size ef 10mm catalog #: 42555805110 lot #: 65314961, persona tapered cemented stem extension 14mm x +75mm catalog #: 42560007514 lot #: 65265670, persona tapered cemented stem extension 14mm x +75mm catalog #: 42560007514 lot #: 65265694, persona central tibial cone size small catalog #: 42545000511 lot #: 64815926, persona revision cemented femoral component left size 9+ catalog #: 42504606611 lot #: 65324144, persona cemented distal augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 65047249, persona cemented distal augment size 9, 9+ 10mm catalog #: 42556606610 lot #: 65042398, persona cemented posterior augment size 9, 9+ 5mm catalog #: 42556806605 lot #: 65324428 the complainant has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision due to ligament laxity and instability approximately three (3) years post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review, however, the reported event of instability could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental 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 POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 14MM
• 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22075465
• Report Number: 3007963827-2025-00211
• Device Sequence Number: 18485368
• Product Code: MBH
• UDI-Device Identifier: 00889024238091
• UDI-Public: (01)00889024238091(17)270125(10)65279785
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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
• Report Date (Section B): 06/06/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512600714
• Device Lot Number: 65279785
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male