MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL ARTICULAR SURFACE SIZE GREEN/E,F 10 MM HEIGHT; INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the product was received fractured in a rotating kit.There was no patient involvement.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h6 complaint sample was returned and evaluated against the reported event.Visual examination of the product identified signs of use, nicks and gouges, and is fractured.Dimensional analysis of the product determined that the product was conforming to print specification.Not all pieces were returned.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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: PROVISIONAL ARTICULAR SURFACE SIZE GREEN/E,F 10 MM HEIGHT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11216372
• MDR Text Key: 228442864
• Report Number: 0001822565-2021-00212
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00889024225909
• UDI-Public: (01)00889024225909(10)63025941
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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: 00599504010
• Device Lot Number: 63025941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1