MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RLOC TRIPOLAR 36MMOD22MMIDSZ24; PROSTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 04/28/2014

Event Type  Injury  

Event Description

Patient's legal counsel reported patient underwent an initial right hip arthroplasty on (b)(6) 2004.Legal counsel further reports patient allegations of pain, swelling, inflammation, loss of range of motion, damage to surrounding bone/tissue, lack of mobility, elevated metal ion levels, metal poisoning, and metallosis.Additional information provided in patient medical records indicate that the right revision procedure was performed on (b)(6) 2014 due to polyethylene wear.The patient¿s operative report noted scar tissue and removal of head, cup and liner.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 1 states, ¿material sensitivity reactions.¿ number 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 11 states, "wear and/or deformation of articulating surfaces." 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 1825034-2014-03927 and 05684).

• Brand Name: RLOC TRIPOLAR 36MMOD22MMIDSZ24
• 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: 3887126
• MDR Text Key: 4653381
• Report Number: 0001825034-2014-05684
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK991990
• 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: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/01/2008
• Device Model Number: N/A
• Device Catalogue Number: 11-165200
• Device Lot Number: 401880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2003
• 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: 54 YR