MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM COCR MODULAR HEAD +6MM NO SKIRT; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 08/07/2002

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a right total hip arthroplasty on (b)(6) 2001.Subsequently, patient's legal counsel reported patient was revised on (b)(6) 2002 due to patient allegations of pain, bone/tissue damage, loss of range of motion, elevated metal ion levels and metallosis.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received in patient¿s operative (op) notes dated (b)(6) 2002 reports the presence of hypertrophic fibrosis around the hip joint with a thickened hip capsule, synovial fluid, loosening of acetabular component.The modular head and cup were removed and replaced.Review of invoice records indicates the cup was replaced with competitor product.

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.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 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ number 15 states, ¿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 2 of 2 mdrs filed for the same event (reference 1825034-2014-05585 and -06499).

• Brand Name: 28MM COCR MODULAR HEAD +6MM NO SKIRT
• 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: 3968983
• MDR Text Key: 4625239
• Report Number: 0001825034-2014-06499
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK971558
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 163638
• Device Lot Number: 998860
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2001
• 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: 63 YR