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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2020

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 knee instrument was returned fractured.There is no additional information available at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6 complaint sample was evaluated and the reported event was confirmed.Visual exhibits signs of repeated use and the post feature has fractured off.Device history record (dhr) were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.Supplier dhr¿s were reviewed for deviations and/or anomalies and one non-conformance was found.A definitive root cause cannot be determined.Evaluation of the returned device identified the fracture was consistent with the tasp fractures analyzed in zrm_wa_0496_18.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE CD
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10004371
• MDR Text Key: 189870682
• Report Number: 0001822565-2020-01518
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024244962
• UDI-Public: (01)00889024244962
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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: 42527000303
• Device Lot Number: 63813258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1