MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER BIOLOXD MOD HD 36MM -3 NK; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 04/25/2011

Event Type  Injury  

Event Description

Patient's legal counsel reported patient underwent left total hip arthroplasty on (b)(6) 2006.Legal counsel further reports patient underwent revision (b)(6) 2008 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, soreness, dysfunction, loss of range of motion, metallosis, metal poisoning, and elevated metal ion levels.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Additional information received in patient medical records revealed the (b)(6) 2008 revision was due to pain.The patient¿s operative report noted acetabular component had small area of bone ingrowth.Additional information received in patient medical records revealed another revision was performed on (b)(6) 2011 due to pain.The patient¿s operative report noted osteolytic bone.

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 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." 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 patient (reference 1825034-2014-06704 / 06705 and 08589).

• Brand Name: CER BIOLOXD MOD HD 36MM -3 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: 4240990
• MDR Text Key: 5066048
• Report Number: 0001825034-2014-08589
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061312
• 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: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 12-115120
• Device Lot Number: 792310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2008
• 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: 56 YR