MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COCR TROCH CABLE 2.0MMX750MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Tissue Damage (2104); Discomfort (2330); Toxicity (2333); Disability (2371); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/20/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent total hip arthroplasty on (b)(6) 2008.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013, due to patient allegations of pain, discomfort, soreness, dysfunction, loss of mobility, damage to bone/tissue, metallosis, and elevated metal ion levels.A review of the invoice history confirmed the surgery dates and that the modular head, taper adapter and acetabular cup was removed and replaced during the revision surgery.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information (b)(6) 2013 was due to pain and elevated metal ion levels.The patient¿s operative report noted synovial fluid that was metal-tinged, soft tissue reaction, metallosis, metal reactive debris, lytic lesion, bone loss, and osteolysis.Additional information received in patient medical records noted that on (b)(6) 2013 patient¿s blood was tested.

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 1 states, ¿material sensitivity reactions.¿ number 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ 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 3 of 3 mdrs filed for the same event (reference 1825034-2014-04271 / 04272 and -07139).

• Brand Name: COCR TROCH CABLE 2.0MMX750MM
• 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: 4018004
• MDR Text Key: 4877616
• Report Number: 0001825034-2014-07139
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982545
• 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: 07/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• 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: 120002
• Device Lot Number: 131760
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2008
• 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: 55 YR