MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DEPTH GAUGE; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not 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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the depth gauge broke while the screw size of the acetabulum was being measured.Attempts have been made and no additional information is available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definitive root cause cannot be determined with the information provided.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.

• Brand Name: DEPTH GAUGE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7946754
• MDR Text Key: 123070983
• Report Number: 0001822565-2018-05610
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• 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: 00661109800
• Device Lot Number: 62079717
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 57 YR