MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE 11MM RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona stemmed cemented tibial component catalog #: 42532006702 lot #: 66727567, persona posterior stabilized articular surface right 11mm catalog #: 42522400511 lot #: 65780028.G2 - report source - foreign: event occurred in hong kong.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 during knee arthroplasty while the surgeon attempted to insert the articular surface, there was a small gap between the insert and the top of the tibial baseplate after several attempts to seat the device.Another articular surface was opened, however, the surgeon struggled to seat the second implant as well.The second articular surface implant was impacted approximately five (5) times anteriorly with a tibial provisional extractor before it was successfully seated.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.During this reported event, the surgical team used a tibial provisional extractor and mallet to impact the articular surface anteriorly.This is a deviation of the surgical technique, which instructs to apply pressure by hand and use the articular surface inserter to lock the articular surface to the tibial plate.It states to place the bearing onto the tibial base plate and apply pressure anterior to posterior to properly engage the tibial component and tibial bearing for final seating.It also states to steady the surface of the base plate with one hand by applying downward pressure near the posterior cruciate cutout and to engage the hook on the articular surface inserter with the mating slot in the front of the baseplate and close the lever with your index finger.This locks the inserter to the tibial plate.The technique also warns to not impact the articular surface or impact/lever the articular surface inserter or extractor tools when they are attached to the tibial plate as this may disrupt the fixation of the tibial plate to the bone and/or cause damage to the implant or instrument.It further notes to not use any component if it is found to be damaged or becomes damaged during use.However, 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 11MM RIGHT
• 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: 21623981
• Report Number: 3007963827-2025-00099
• Device Sequence Number: 6827966
• Product Code: MBH
• UDI-Device Identifier: 00889024243606
• UDI-Public: (01)00889024243606(17)280708(10)65918175
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K121771
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 42522400511
• Device Lot Number: 65918175
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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.
• Patient Sex: Unknown