MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC FEMORAL 10X140MM LATERALIZED STEM 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Tissue Damage (2104)

Event Date 12/11/2008

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 the 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 1 of 2 mdrs filed for the same patient (reference 1825034-2016-04215 / 04216).

Event Description

Legal counsel for patient reported that patient underwent a right hip revision procedure approximately seven years post implantation.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Operative reports provided noted that during primary implantation a 10mm stem was attempted to be implanted, however, it sat proud.After attempting to resolve the issue through neck resection and using a high speed bur to take off some bone of the medial calcar, the stem was removed and the procedure was completed with a 9mm stem.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.Concomitant products: m2a-magnum modular head: catalog#: 157442, lot#: 958820.M2a-magnum pf cup: catalog#: us157848, lot#: 479180.M2a-magnum taper adapter: catalog# 239254, lot# 481660.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.Concomitant medical product - unknown biomet head, unknown biomet cup, unknown biomet liner.

• Brand Name: TAPERLOC FEMORAL 10X140MM LATERALIZED STEM 12/14 TAPER
• 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: 6045166
• MDR Text Key: 57989743
• Report Number: 0001825034-2016-04215
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 25-103204
• Device Lot Number: 540000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2004
• 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
• Patient Age: 49 YR