MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL; KNEE INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 04/02/2024

Event Type  malfunction  

Event Description

It was reported that the device was fractured.No more information is available.

Manufacturer Narrative

(b)(4).H6: tasp bottom- mechanical (g04) - provisional bottom.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of repeated use and is fractured.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The summary of investigations for complaints associated with the tibial articular surface provisional (tasp) fracture.Fractured tasps were analyzed by optical microscopy revealing hackle marks and river lines in the case of bending overload; and hackle marks, river lines and striations were found in the case of low cycle fatigue culminating in a bending overload failure type.In addition to the visual and optical microscopy analysis, a review of the dhf and dfmea was performed.Ongoing complaint monitoring confirms that the rate of instrument fracture is within the expected risk profile.A definitive root cause cannot be determined.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.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19106675
• MDR Text Key: 340600580
• Report Number: 0001822565-2024-01235
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024245044
• UDI-Public: (01)00889024245044(10)63454805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• 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
• Report Date: 04/15/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42527000707
• Device Lot Number: 63454805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose