MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC POR FMRL 9X137; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Toxicity (2333); Disability (2371); Ambulation Difficulties (2544)

Event Date 06/21/2010

Event Type  Injury  

Event Description

Legal counsel for the patient alleges that patient underwent a total hip arthroplasty on or about (b)(6) 2008.Subsequently, legal counsel for patient reports patient underwent a revision procedure on (b)(6) 2013 due to patient allegations of pain, discomfort, soreness, inflammation, dysfunction, lack of mobility and range of motion, metal poisoning/elevated metal ion levels, and metallosis.Review of invoice history shows a total hip arthroplasty procedure occurred on (b)(6) 2008 and a revision procedure on (b)(6) 2010 where the head, taper insert, and stem were removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history record shows 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 1 states, "material sensitivity reactions." number 6, "inadequate range of motion due to improper selection or positioning of components." number 14, "intraoperative or postoperative bone fracture and/or postoperative pain.And number 15, "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 3 of 7 mdrs filed for the same event (reference 1825034-2014-01492 / -01498).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Event Description

Legal counsel for the patient alleges that patient underwent a total hip arthroplasty on or about (b)(6) 2008.Subsequently, legal counsel for patient reports patient underwent a revision procedure on (b)(6) 2013 due to patient allegations of pain, discomfort, soreness, inflammation, dysfunction, lack of mobility and range of motion, metal poisoning/elevated metal ion levels, and metallosis.Review of invoice history shows a total hip arthroplasty procedure occurred on (b)(6) 2008 and a revision procedure on (b)(6) 2010 where the head, taper insert, and stem were removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received in operative report noted patient underwent a right hip revision on (b)(6) 2010.Operative report noted the presence of a loose stem and fibrotic tissue.The modular head, taper adapter and stem were removed and replaced.Operative report further noted patient underwent an additional revision on (b)(6) 2010 due to lack of mobility.Operative report noted the stem was loose and the acetabular cup was loose and malpositioned.All components were removed and replaced with competitor components.

• Brand Name: TAPERLOC POR FMRL 9X137
• 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: 3672223
• MDR Text Key: 4339460
• Report Number: 0001825034-2014-01494
• 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,Followup
• Report Date: 03/02/2015

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 103203
• Device Lot Number: 355420
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 03/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2008
• 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: 39 YR
• Patient Weight: 136