MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROTHESIS HIP

Model Number N/A

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet."from the investigation we can conclude that the hair was present in the opened package however when the hair was placed in the package cannot be determined.A quality alert has been initiated to address and re-train operators on the importance of checking for contaminates." review of complaint history found no additional related issues for this item.Review of device history records found an unrelated deviation during the manufacturing process.The nonconformance was scrapped.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that during an initial total hip arthroplasty on (b)(6), when the sales rep opened the cup, a small black hair was found on the sterile foam inside the sterile barrier.Another cup was used to complete the procedure.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• Type of Device: PROTHESIS 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: 6943452
• MDR Text Key: 90301405
• Report Number: 0001825034-2017-08561
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• 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: 010000663
• Device Lot Number: 3616406
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1