MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC); 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	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the surgeon a device was not locking to mating device.He used the bearing inserter to complete the process however it did not to lock into the tray.The normal click sound was absent when the bearing inserter was used.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual examination of the returned product identified damage to the distal surface (nicked/gouged) and the locking feature (dovetail) is found to be slightly flared out.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 MEDIAL CONGRUENT (MC)
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12939740
• Report Number: 3007963827-2021-00314
• Device Sequence Number: 4830634
• Product Code: MBH
• UDI-Device Identifier: 00889024468979
• UDI-Public: (01)00889024468979(17)250331(10)64726609
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/14/2021

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 Expiration Date: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 42512100410
• Device Lot Number: 64726609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• 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: 11/09/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2020
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Female