MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC POR LAT FMRL 11X142; PROSTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Granuloma (1876); Complaint, Ill-Defined (2331); Osteolysis (2377)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Patient's legal counsel reported that patient underwent right total hip arthroplasty on (b)(6) 2006 and a revision procedure on (b)(6) 2014.Patient medical records provided by legal counsel indicates bearing surface wear, osteolysis, synovial granuloma, grayish-blackish synovial fluid and hypertrophic metallosis were noted during the revision procedure.Revision operative report further indicates that an osteotomy was needed to remove the femoral stem as the stem and taper were cold welded.All components were removed and replaced with a biomet metal-on-polyethylene total hip during the revision procedure.A competitor cerclage and cables were placed around the distal femur above the osteotomy.

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.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 4 of 4 mdrs filed for the same event (reference 1825034-2015-00946 & 00977 & 00978 & 00979).

• Brand Name: TAPERLOC POR LAT FMRL 11X142
• 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: 4598623
• MDR Text Key: 5697526
• Report Number: 0001825034-2015-00979
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/17/2015

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: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-103205
• Device Lot Number: 695740
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2006
• 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: 60 YR