MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT TRL THN 37 3 PEG; INSTRUMENT, KNEE

Catalog Number 32-484788

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the patella trial was found fractured during kit inspection.No patient or surgical involvement.No further information is available at this time.

Manufacturer Narrative

His follow-up report is being submitted to relay additional information.Visual examination of the returned product confirms the reported material fracture.One peg has fractured away from the device.Review of device history record was not possible as the necessary product/lot code combination was not provided.The root cause is unknown.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 information is available at this time of this reporting.

• Brand Name: SERIES A PAT TRL THN 37 3 PEG
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8524099
• MDR Text Key: 142256425
• Report Number: 0001825034-2019-01687
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

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 Catalogue Number: 32-484788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1