MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER BIOLOXD OPTION HD 28MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Hematoma (1884); Inflammation (1932); Necrosis (1971); Pain (1994); Swelling (2091); Toxicity (2333); Joint Dislocation (2374)

Event Date 10/28/2013

Event Type  Injury  

Event Description

Patient's legal counsel reported that patient underwent total hip arthroplasty on (b)(6) 2004.Legal counsel for patient reports patient allegations of pain and clicking noises.Subsequently, additional information received indicates patient was revised on (b)(6) 2013 due to metallosis.The modular head was removed and replaced.Additional information received from patient¿s legal counsel reports patient underwent a left hip revision due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, difficulty walking, leg length discrepancy, squeaking, elevated metal ion levels, metal poisoning, metallosis, and lack of mobility.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Operative report noted patient underwent an additional left hip revision on october 28, 2013 due to dislocation.Revision operative report noted the presence of necrosis, a hematoma, and black metallic stained tissue.The modular head and acetabular cup were removed and replaced.

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 related to the patient.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." 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 1825034-2013-0181304194 & 2014-07389 /-07390).

• Brand Name: CER BIOLOXD OPTION HD 28MM
• 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: 4044406
• MDR Text Key: 19086267
• Report Number: 0001825034-2014-07390
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• 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: 07/30/2014

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: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 554760
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR