MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 NEUTRAL ARCOMXL LNR 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Blood Loss (2597)

Event Date 04/14/2016

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 2 of 2 mdrs filed for the same patient (reference 1825034-2016-01592 / 01593).

Event Description

During a procedure, the liner would not seat in the cup.Tissue and bone were cleared and the liner was attempted to be seated multiple times.Another liner was attempted to be used, however it would not seat in the cup after multiple attempts.The cup was removed from the patient.Another cup and third liner were used to complete the procedure.There was a 45 minute delay in procedure and the patient required a blood transfusion.

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).Review of device history and manufacturing records found no evidence of product non-conformance.Visual inspection shows evidence of scratches and deformation most likely from the customer attempting to seat the liners into the cup from is noted on the device.Dimensional measurement of the liners showed nonconformance to print specification due to surface deformed from when the surgeon attempt to seat these liners in the cup.A conclusive root cause could not be determined without additional information.There are warnings in the package insert that state that this type of event can occur: under warnings, it states, "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.".

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM 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: 5653666
• MDR Text Key: 45148301
• Report Number: 0001825034-2016-01593
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000742
• Device Lot Number: 3480270
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR