MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IMPACTOR FOR USE WITH 44 MM I.D. CUP; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2018

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 metal debris and a crack were found on the impactor.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: it was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.

Manufacturer Narrative

This report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.As returned, cracks, gouges, and metal debris were seen in the impactor cap.The device exhibited wear and tear that was indicative of repeated use during a potential field age of approximately 6 years 1 month.It is unknown how many times the device was used during this field life.Dhr review not required.This issue is associated with a previously addressed capa.A definite 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.

Event Description

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

• Brand Name: IMPACTOR FOR USE WITH 44 MM I.D. CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8070226
• MDR Text Key: 127214754
• Report Number: 0001822565-2018-06452
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151603044
• Device Lot Number: 62171803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• 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