MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC); PROSTHESIS KNEE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

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 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.

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 Description

No further event information available at the time of this report.

• Brand Name: PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC)
• Type of Device: 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
• MDR Text Key: 285551875
• Report Number: 3007963827-2021-00314
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468979
• UDI-Public: (01)00889024468979(17)250331(10)64726609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female