MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NECK PROVISIONAL A; PROSTHESIS, HIP

Model Number N/A

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2018

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 that the neck trail was cracked and was found while arranging the trays.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This report is being submitted to relay corrected information.Upon reassessment of the reported event, it was determined to be not reportable as this component did not cause serious injury, and this malfunction has not previously been reported for causing serious injury.

• Brand Name: NECK PROVISIONAL A
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7297826
• MDR Text Key: 101154634
• Report Number: 0001822565-2018-00665
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK110836
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00780501100
• Device Lot Number: 63279318
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1