MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPS III SINGLE KIT W/30ML ACDA; BIOLOGICS

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Based on device history records, the product was made to print and correct materials.Product left conforming to print as there was no evidence that states otherwise.The gps kit had an opened sterile component as stated in the complaint.The seal on the item in question shows an initial perfect seal with no ¿bird eggs¿ that would cause a seal to fail.The anticoagulant solution also has a needle mark on the container showing it has been used.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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

It was reported that during a total hip arthroplasty, the gps kit was opened and one of the sterile components was already opened.Another unit was used to complete the procedure without delay.No adverse events have been reported as a result of the malfunction.

• Brand Name: GPS III SINGLE KIT W/30ML ACDA
• Type of Device: BIOLOGICS
• 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: 6954082
• MDR Text Key: 90535256
• Report Number: 0001825034-2017-08791
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PBK070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 800-1003A
• Device Lot Number: 402677
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2015
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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