MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM DIA COCR MOD HD +9MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Necrosis (1971); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Osteolysis (2377); Reaction (2414); Ambulation Difficulties (2544); Foreign Body In Patient (2687); Test Result (2695)

Event Date 10/23/2013

Event Type  Injury  

Event Description

Patient reported a right total hip arthroplasty was performed (b)(6) 1999.Patient alleges difficulty walking/climbing, lump on hip with metal fragments, peripheral neuropathy, and bone/muscle loss and damage.Subsequently, medical records reveal patient was revised on (b)(6) 2013 due to a cystic mass and osteolysis of greater trochanter.The patient¿s operative report noted corrosion at taper adapter junction, swelling, possible reactive synovitis, cystic material, cloudy brown-colored fluid, caseous brown material, brown staining material, osteolysis, and necrotic tissue.The patient¿s operative report also noted that all biomet components were removed and replaced with competitor products during the revision procedure.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 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, number 4 states, ¿damage to blood vessels, hematoma, delayed wound healing and/or infection.¿ number 5 states, ¿temporary or permanent nerve damage may result in pain and numbness.¿ number 6 states, ¿material sensitivity reactions.¿ number 10 states, ¿periarticular calcification or ossification, with or without impediment of joint mobility.¿ number 15 states, ¿fretting and crevice corrosion can occur between components.¿ this report is number 2 of 3 mdrs filed for the same event (reference 1825034-2014-07760 / 07762).

• Brand Name: 28MM DIA COCR MOD HD +9MM NK
• 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: 4096912
• MDR Text Key: 4762897
• Report Number: 0001825034-2014-07761
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK911684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2009
• Device Model Number: N/A
• Device Catalogue Number: 163665
• Device Lot Number: 882860
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/1999
• 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: 77 YR