MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 36MM COCR MOD HD +6MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Necrosis (1971); Pain (1994); Synovitis (2094); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Test Result (2695)

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent a right total hip arthroplasty on (b)(6) 2008.Subsequently, patient was revised on (b)(6) 2012 due to patient allegations of pain, soft tissue damage/death, bone damage/death, metallosis, elevated metal ion levels, metal toxicity.Lawsuit alleges the presence of reactive synovitis, a black cyst, black hip synovitis, and tan-yellow to gray-brown bone during the revision procedure.Lawsuit further alleges a hip dislocation at an unknown date since the revision surgery.This report is based on allegations set forth in patient¿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 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: under possible adverse effects: "material sensitivity reactions.¿ and "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 7 of 7 mdrs filed for the same event (reference 1825034-2014-01606/-01607/-01608/-01609/-01651/-01652/-01653).

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 patient reported that patient underwent a right total hip arthroplasty on (b)(6) 2008.Subsequently, patient was revised on (b)(6) 2012 due to patient allegations of pain, soft tissue damage/death, bone damage/death, metallosis, elevated metal ion levels, metal toxicity.Lawsuit alleges the presence of reactive synovitis, a black cyst, black hip synovitis, and tan-yellow to gray-brown bone during the revision procedure.Lawsuit further alleges a hip dislocation at an unknown date since the revision surgery.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Operative report received noted patient underwent a right hip revision on (b)(6) 2012.Operative report noted the presence of a black synovium, a black cyst in the ischium, and the taper adapter was cold welded onto the stem.The modular head, taper adapter and acetabular cup were removed and replaced.

• Brand Name: 36MM COCR MOD HD +6MM
• 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: 3675866
• MDR Text Key: 18812960
• Report Number: 0001825034-2014-01653
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK032396
• 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: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-363664
• Device Lot Number: 837480
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2009
• 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