MAUDE Adverse Event Report: BIOMET UK LTD G7 SCREW 6.5MM X 30MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Bent (1059); Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015.During the procedure, the screw head was protruding while being inserted in the acetabular cup.The screw was removed and it was noted the screw was bent.An additional hold was drilled and a new screw was utilized to complete the procedure.

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015.During the procedure, the screw head was protruding while being inserted in the acetabular cup.The screw was removed and it was noted the screw was bent.An additional hold was drilled and a new screw was utilized 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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Dimensional evaluation found component to be within appropriate design specification.During the evaluation, it was noted the root cause of the event was likely due to malalignment of the screw when it was inserted into the cup.

• Brand Name: G7 SCREW 6.5MM X 30MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD; waterlon industrial estate; bridgend, south wales CF31 3XA
• 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: 4735512
• MDR Text Key: 5775577
• Report Number: 0001825034-2015-01719
• Device Sequence Number: 1
• Product Code: LPH
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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: 010000999
• Device Lot Number: 3422846
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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