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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported from the wir form that a persona knee instrument was returned and reported fractured.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Verified item lot combination and reviewed manufacturing date as returned item exhibits signs of repeated use the post feature has fractured off also has fractured on the lateral side of the post feature all pieces were returned reference attached photographs.The device history records & receiving inspection report were reviewed for deviations and/ or anomalies with no deviations/anomalies identified.Medical records were not provided.Investigation into this issue determined that the likely root cause for the tasp fractures is bending/torsional loading on the device.A notification was sent to the field on august 7th, 2014 to provide additional clarifications relating to the instructions for use of the tasp construct for all persona users on file at the time of the field notice (reference z-2578-2014).Ps tasp top components and standard (non-cps) tasp bottom components have been modified to prevent fracture.The fractured tasp component in this complaint was manufactured before the design modification.The root cause is considered to be a previously addressed design issue.

Event Description

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

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11343298
• MDR Text Key: 232374309
• Report Number: 0001822565-2021-00449
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42527000505
• Device Lot Number: 62305410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2578-2014
• Patient Sequence Number: 1