MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 NEUTRAL E1 LINER 32MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Blood Loss (2597)

Event Date 08/09/2016

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 3 mdrs filed for the same patient (reference 1825034-2016-03550/ 03551/03552).Device location unknown.

Event Description

During a total hip arthroplasty, the liner could not be fully seated in shell.When the liner was impacted again, the shell was dislodged and had to be placed again.A second and third liner were attempted to be implanted; however, would not seat in the shell.A fourth liner was used to complete the procedure.There was a 1-2 hour delay in procedure as a result and the patient required a blood transfusion and antibiotic agent feeding.

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 filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the event was confirmed.Visual inspection of the liner shows damage to the liner, likely from attempted implantation and removal, confirming the complaint.With the damage, dimensional analysis could not be completed.Cmm measurement of the shell found no deviations from the print specifications.Dhr was reviewed and no discrepancies were found.Complaint history review identified that no further actions are required.Root cause of the event could not 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

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

• Brand Name: G7 NEUTRAL E1 LINER 32MM H
• Type of Device: PROSTHESIS, 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: 5939340
• MDR Text Key: 54312286
• Report Number: 0001825034-2016-03550
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000852
• Device Lot Number: 3328493
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• 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
• Patient Outcome(s): Required Intervention