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

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Information (3190)

Event Date 07/20/2016

Event Type  No Answer Provided  

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.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-03168 / 03169).Product requested, not yet received.

Event Description

During a total hip arthroplasty, two liners that the surgeon attempted to implant would not seat in the cup.A third liner was used to complete the procedure after an unknown delay.

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

Examination of device records found no evidence of product non-conformance.Review of the device was unable to confirm the reported complaint.Dimensional analysis revealed several measurements were out of tolerance; however, this is likely due to deformation noted along the rim and dome from unsuccessful attempts to impact the liner into the cup.A conclusive root cause of the event could not be determined with the available information.Corrective action has been initiated to address the reported issue.

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).

• Brand Name: G7 NEUTRAL E1 LINER 32MM G
• 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: 5887240
• MDR Text Key: 52510353
• Report Number: 0001825034-2016-03169
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000851
• Device Lot Number: 3521088
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• 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