MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M/H RADIAL SOLID/APX SHL 52MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 02/25/2014

Event Type  Injury  

Event Description

It was reported patient underwent a total hip arthroplasty on (b)(6) 2014.While impacting the cup into the acetabulum, the cup released prematurely from the inserter handle.As the cup was removed from the patient, it was noted threads from the inserter were stuck in the cup.A new cup 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.

• Brand Name: M/H RADIAL SOLID/APX SHL 52MM
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3705448
• MDR Text Key: 4262348
• Report Number: 0001825034-2014-02223
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK921181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 13-104052
• Device Lot Number: 056460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2013
• 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