MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS HIP

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.: from the investigation we can confirm that the g7 shell was conforming to specification in accordance with the packaging procedure and evidence documented in the investigation.No discrepancies or issue have been recorded on the manufacturing history records.The tyvek lid adhesion around the blister and tyvek contact surface was well covered and constant around the perimeter of the blister.The blister / tyvek burst and peel tests are carried out at the start of every shift, or when the packaging needs to be replaced for a different product.The production logs attached in etq confirm that this had taken place and that the sealing process was conforming at the time of the shell being packaged and sealed.Review of complaint history found no additional related issues for this item.Review of device history records found unrelated deviations during the manufacturing process.The nonconformances were: 1 unit had chipped coating around the apex hole.The part was scrapped; 5 units were reworked due to rough coating.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 an initial total hip arthroplasty on (b)(6) 2016, the inner packaging seal was noted to be broken.The surgery was completed with a different device with no delay.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• 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: 6929961
• MDR Text Key: 89999905
• Report Number: 0001825034-2017-08268
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• 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: 010000664
• Device Lot Number: 3671995
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1