MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT STEM REMOVAL JAW; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 tip of the stem extractor fractured during hip revision surgery.Attempts have been made and no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.One exact stem removal jaw was returned and evaluated.Upon visual inspection the device has disassociated between the main body & slap hammer connector.The threaded end was fractured from the rest of the jaw and the threads are mostly sheared off.The device was sent for fracture analysis and the analysis identified the fracture artifacts suggest a tensile overload fracture of the weld & longitudinal shearing of the threads.It is unknown which fracture occurred first and was not able to be determined.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definitive root cause could not 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: EXACT STEM REMOVAL JAW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7902520
• MDR Text Key: 121564673
• Report Number: 0001825034-2018-09085
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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: X31-400060
• Device Lot Number: 475832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1