MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC POR RED/LAT 17.5X155; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Scarring (2061); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 12/01/2006

Event Type  Injury  

Event Description

Legal counsel for the patient reported that patient underwent m2a hip arthroplasty on (b)(6) 2004.Subsequently, patient was revised on (b)(6) 2006 allegedly due to pain, swelling, tissue and bone damage, fluid buildup, lack of mobility, metallosis and pseudotumours.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 left hip revision procedure on (b)(6) 2006 due to pain and femoral loosening.Operative report further noted scarring, trochanteric bursitis, thickening of the tensor fascia and synovitis.The modular head and femoral stem were removed and replaced.

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: "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." this report is number 3 of 3 mdrs filed for the same event (reference 1825034-2012-01664 / 01665 & 2015-01928).

• Brand Name: TAPERLOC POR RED/LAT 17.5X155
• 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: 4753147
• MDR Text Key: 16176448
• Report Number: 0001825034-2015-01928
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK921301
• 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: 04/24/2015

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: 03/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 13-103209
• Device Lot Number: 645830
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2004
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR