MAUDE Adverse Event Report: BIOMET UK LTD. G7 ACETABULAR SYSTEM, G7 NEUTRAL E1 LINER 32MM C; PROSTHESIS, HIP

Catalog Number 010000847

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an initial hip procedure a box for a 32 c liner was opened and found to have the incorrect implant inside.The surgery was delayed by twenty minutes but was completed using another device.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint cannot be confirmed as the device was with found to be of correct size the product was returned with the package.Dimensional analysis of the device confirms that the liner is a size c.Visual inspection of the device exhibited damage which possibly caused during insertion of the shell.The hole through the rim looks like it was caused by a screw.The spiral thread marks inside the hole can be caused if the surgeon has used a screw to assist with removal of a liner.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.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.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable.Upon investigation it was found the alleged complaint did not occur and there was no product issue as device did not malfunction in anyway.The initial report was submitted in error and should be voided.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: G7 ACETABULAR SYSTEM, G7 NEUTRAL E1 LINER 32MM C
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6412855
• MDR Text Key: 70312505
• Report Number: 3002806535-2017-00147
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/30/2019
• Device Catalogue Number: 010000847
• Device Lot Number: 3449908
• Other Device ID Number: (01) 0 08 80304 52633 4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• 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
• Patient Age: 50 YR