MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM DRIVER; PROSTHESIS HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will be 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 during stem implantation, handle of inserter cracked.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection of the device identified fracture of the handle into two pieces at the handle pin junction.All pieces were returned.Wear and tear was identified on the device indicative of numerous uses during the field life.The potential field age of the device was determined to be approximately 10 years.It is unknown how many times the device was used during this field life.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was 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: STEM DRIVER
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8224871
• MDR Text Key: 132347641
• Report Number: 0001822565-2019-00072
• Device Sequence Number: 1
• Product Code: HWR
• 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: 04/11/2019

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 Model Number: N/A
• Device Catalogue Number: 00771205700
• Device Lot Number: 61167175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1