MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR LINER HIGH WALL 36MM SIZE F; PROSTEHSIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Component or Accessory Incompatibility (2897); Device Dislodged or Dislocated (2923)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.Udi# (b)(4).Investigation into this issue is ongoing and when additional information is received, a follow-up report will be submitted to the fda.

Event Description

During a total hip arthroplasty, when trialing the head, the liner dislodged from the shell.The surgeon attempted to impact the liner again but it would not seat in the acetabular shell.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Indentations and markings were present on the internal sphere of the which may have been caused at the stage of the trail head being fitted , however this cannot be determined.The external sphere of the liner was free from marks and damage, with the locking ridge being intact with no visible defects or issues.All etching was correct to the manufacturing records.Dhr was reviewed and no discrepancies were found.Root cause could not be determined with information available.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 LINER HIGH WALL 36MM SIZE F
• Type of Device: PROSTEHSIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6096936
• MDR Text Key: 59754761
• Report Number: 0001825034-2016-04678
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000936
• Device Lot Number: 3702460
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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