MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING LEFT 10 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.D10: 42-5320-067-01, tibia cemented 5 degree stemmed left size d, 67030119.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the surgery, multiple attempts were made to insert a 10mm articular surface implant while carefully maintaining the correct insertion direction.Despite these efforts, the backside of the implant became deformed, preventing successful placement.Ultimately, the procedure was completed successfully with an alternative 10mm articular surface.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: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6; complaint can be confirmed.Visual examination of the returned product identified one corner of the dovetail side is fractured off.The dovetail itself is damaged and is compressed and flared on both sides.The extractor slot is also nicked and gouged.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device was submitted for further analysis.Analysis determined: no significant damage is noted on the superior side but on the inferior side, the edge of the medial condyle is apparently fractured off.The fractures on the medial condyle are also surrounded by several similarly shaped gouges, as if the item was struck repeatedly against a hard object in that area.The fracture itself does not appear to be a sudden clean fracture, but possibly the results of several blows causing a pinching or tearing effect.It was noted that the locking mechanism was flared or flattened or dented and part of the locking mechanism is gouged along the side.Conclusion: it cannot be determined what prevented the bearing surface from inserting and seating properly, but the failure to properly seat resulted in damage to the locking mechanism by repeated mispositioned contact with the tibial tray.Damage from the unsuccessful attempts to seat the bearing potentially eventually made it impossible to properly seat the bearing, at which point replacing the bearing was necessary.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as a failure to follow instructions.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.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 ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING LEFT 10 MM
• 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: 22372429
• Report Number: 3007963827-2025-00263
• Device Sequence Number: 17304317
• Product Code: MBH
• UDI-Device Identifier: 00889024235045
• UDI-Public: (01)00889024235045(17)291025(10)66972874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512000410
• Device Lot Number: 66972874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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
• Patient Sex: Unknown