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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer had indicated that the product was being returned to zimmer biomet for investigation, but it has not yet been received.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the tasp was found broken during clean up after an initial procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d10; g4; g7; h1; h2; h3; h6 complaint sample was evaluated and the reported event was confirmed.Visual examination exhibits signs of repeated use and has fractured on the lateral side of the post feature.Device history record (dhr) was reviewed and no discrepancies were found.Supplier dhr for job no.N0004152 was reviewed for anomalies with 2 process deviation and non-conformance reported: 1st has 21 parts scrapped at laser marking operation (500) affecting 21 parts and were scrapped.Root cause not identified.Operators allowed to scrap parts within operation if deemed unacceptable.2nd has parts have damage and burrs that caused rework in operation 600 affecting 48 part and were scrapped.48 parts scrapped that could not be reworked.Tumbling process too aggressive and burrs due to dull tooling or incorrect tool speed.Parts100% visually verified at final inspection.A definitive root cause cannot be determined.Evaluation of the returned device identified the fracture was consistent with the tasp fractures analyzed in a zrm, which 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 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: TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE CD
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10501629
• MDR Text Key: 206090067
• Report Number: 0001822565-2020-03172
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024238459
• UDI-Public: (01)00889024238459
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• 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: 42517000303
• Device Lot Number: 63808393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1