MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-MAGNUM PF CUP 52ODX46ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Necrosis (1971); Pain (1994); Weakness (2145); Toxicity (2333); Osteolysis (2377); Reaction (2414); Fluid Discharge (2686)

Event Date 09/24/2014

Event Type  Injury  

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 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ 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." this report is number 2 of 2 mdr's filed for the same event (reference 1825034-2015-00148-1 / 05109).

Event Description

It was reported that the patient underwent a right total hip arthroplasty on (b)(6) 2009.Subsequently, a revision procedure was performed on (b)(6) 2014, due to patient allegations of pain and weakness.The patient reports that bone deterioration was allegedly noted during the revision procedure.The head was removed and replaced with a liner and head.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received reported that the revision procedure on (b)(6) 2014 occurred due to allegations of pain and aseptic loosening.During the procedure, fluid with necrotic tissue, necrosis of the sapsule and synovium, well-fixed stem, loose cup which had migrated to abducted position, mild metallosis and necrotic acetabular bone were noted.The head and cup were removed and replaced, and a liner was implanted to complete the procedure.

• Brand Name: M2A-MAGNUM PF CUP 52ODX46ID
• 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: 5322633
• MDR Text Key: 34245852
• Report Number: 0001825034-2015-05109
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: US157852
• Device Lot Number: 947850
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2009
• 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: 67 YR