MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM COCR MOD HD +6MM NO SKIRT; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment Of Device Component (1104); Material Deformation (2976)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 09/09/2015

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 possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.".

Event Description

It was reported patient underwent a total hip arthroplasty on an unknown side on (b)(6) 2015.Subsequently, the patient was revised on (b)(6) 2015 due to the femoral head disengaging from the hip stem.The explanted femoral head was found to have metal burr inside the taper.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Visual examination did not find a burr on the modular head.A conclusive root cause could not be determined.

• Brand Name: 32MM COCR MOD HD +6MM NO SKIRT
• 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: 5138163
• MDR Text Key: 27909071
• Report Number: 0001825034-2015-04168
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK974558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 02/29/2016

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 Model Number: N/A
• Device Catalogue Number: 163674
• Device Lot Number: 273070
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• 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): Hospitalization; Required Intervention