MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 STR MONOBLOCK SHELL INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 07/06/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial total hip arthroplasty on (b)(6) 2015.During the procedure, the g7 inserter would not disengage from the shell after being impacted into the acetabulum.Another straight handle was available and a new shell of the same size was used to complete the procedure.

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 precautions, it states, "biomet recommends that all instruments be regularly inspected for wear and disfigurement prior to use." evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Root cause is undetermined as the shell is completely stuck on the inserter and unable to disassemble to find root cause.

• Brand Name: G7 STR MONOBLOCK SHELL INSERTER
• 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: 4943899
• MDR Text Key: 6252207
• Report Number: 0001825034-2015-03287
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 073120
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention