MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS; PROSTHESIS, HIP

Catalog Number 00875306001

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported that a 60 mm trilogy shell was opened and given to scrub nurse during surgery.The fiber metal had a sharp wire fiber sticking up and perforated 1st layer of surgical gloves but not the 2nd.No skin was in contact with fiber metal prong.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted report source: (b)(6).

Event Description

No additional information on the reported event.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Fiber metal wire was found to be sticking out in two locations.One piece at the top threaded hole and also at the outer diameter of the shell.No other damage was noted.No other loose wires were felt during evaluation.Review of the device history records identified no (related) deviations or anomalies during manufacturing.The root cause is determined to be manufacturing issue.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: SHELL WITH CLUSTER HOLES POROUS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12983016
• MDR Text Key: 282099108
• Report Number: 0001822565-2021-03561
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 0088902415056
• UDI-Public: (01)0088902415056(17)210108(10)64905048
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00875306001
• Device Lot Number: 64905048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1