MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-T UNIV 2-HOLE SHL SZ 41/62; PROSTHESIS, HIP

Model Number N/A

Device Problems Break (1069); Device Slipped (1584); Positioning Problem (3009)

Patient Problems Scar Tissue (2060); Osteolysis (2377); Fluid Discharge (2686)

Event Date 01/21/2008

Event Type  Injury  

Event Description

It was reported that patient underwent a left total hip arthroplasty on an unknown date.Subsequently, a revision procedure has been indicated due to an unknown reason; however, no revision procedure has been reported to date.Additional information received in the revision operative report noted patient underwent a left hip revision on (b)(6) 2014 due to protrusio of the hip.Revision operative report noted the presence of clear serosanguineous fluid, scar tissue, a deficient medial wall, loose acetabular cup, broken screws, and fibrous tissue.The modular head, liner and acetabular cup were removed and replaced.Patient underwent a right total hip arthroplasty on an unknown date.Subsequently, patient underwent a right revision procedure on (b)(6) 2007 and an additional right hip revision on (b)(6) 2008 due to protrusio of the hip.Osteolysis was noted in the (b)(6) 2008 procedure.The modular head, acetabular cup and liner were removed and replaced on both revisions.

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 related to the event.This report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2014-06966 /-07879 /-07880).

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/62
• 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: 4133696
• MDR Text Key: 4923144
• Report Number: 0001825034-2014-07880
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2014

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: 01/31/2010
• Device Model Number: N/A
• Device Catalogue Number: 15-103692
• Device Lot Number: 991870
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2001
• 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
• Patient Age: 46 YR