MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR LINER HI WALL E1 36MM SIZE G; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, "improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." this report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-03758 / 03759 ).

Event Description

During a total hip arthroplasty, the liner was impacted and thought to be seated in the shell.However, during trialing and range of motion check, the liner popped out of the shell.The liner was again attempted to be impacted, but disassociated from the shell a second time.The liner was attempted to be seated a third time, with the same result.A second liner was attempted to be implanted; however, the second liner also would not seat in the shell.The shell was removed, and a new shell and liner were used to complete the procedure.There was a 15-20 minute delay in procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Manufacturer Narrative

(b)(4).Report source foreign: (b)(6).Concomitant medical products: item# 010000937 g7 hi-wall e1 liner 36mm g lot# 3088478, item# 010000666 g7 pps ltd acet shell 58g lot# 3813921.Complaint sample was evaluated and the reported event was confirmed.Visual inspection noted a dimple was created at the apex of the liner during disassembly.A scratching can be seen on the lower left side of the attached outer radius photo.No damage can be seen on the barb, scallops, rim, or inner radius of the liner.Dimensional analysis on the liner did not find any related deviations/anomalies.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: G7 ACETABULAR LINER HI WALL E1 36MM SIZE G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 5969963
• MDR Text Key: 55364939
• Report Number: 0001825034-2016-03758
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000937
• Device Lot Number: 3530515
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: Not provided; 07/25/2018
• Supplement Dates FDA Received: 12/01/2016; 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR