MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a trial articular surface was returned fractured.Not all pieces were returned.There is no additional information available at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.Corrected: h6 (health effect - impact code & health effect - clinical code).Evaluation of the returned device found it to exhibit signs of repeated use (nicked or gouged) and the post feature has fractured off, all pieces returned.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.Evaluation of the returned device identified the fracture was consistent with the tasp fractures previously analyzed in a zrm.The zrm identified that the common failure modes for the tasp devices include either bending overload or low cycle fatigue culminating in bending overload as evident by the presence of hackle marks, river lines and striations features on the fracture surface.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 Description

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

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11321666
• MDR Text Key: 231619003
• Report Number: 0001822565-2021-00391
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024238497
• UDI-Public: (01)00889024238497(10)64394708
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 42517000505
• Device Lot Number: 64394708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1