MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A MOD HEAD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Device Operates Differently Than Expected (2913); Compatibility Problem (2960)

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330)

Event Date 03/23/2015

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 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." (b)(4).This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-01602 / 01603).Product location unknown.

Event Description

Legal counsel for patient reported that patient underwent a right hip revision procedure approximately thirteen years post-implantation due to alleged pain, discomfort, soreness, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, dysfunction, elevated metal ion levels, metal poisoning, metallosis, and metal debris.Legal counsel reported that brown-colored fluid, pseudotumor, and necrotic areas were allegedly noted during the revision.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Event Description

Legal counsel for patient reported that patient underwent a right hip revision procedure approximately thirteen years post-implantation due to alleged pain, discomfort, soreness, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, dysfunction, elevated metal ion levels, metal poisoning, metallosis, and metal debris.Legal counsel reported that brown-colored fluid, pseudotumor, and necrotic areas were allegedly noted during the revision.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.It was reported in operative notes received that patient underwent a left hip revision procedure approximately 13 years post-implantation due to a greater trochanter fracture.During the procedure, brown fluid, pseudotumor formation and bone defects caused by metal wear were noted.The femoral head and acetabular cup were removed and replaced.A liner was implanted, and a competitor cup was used to complete the procedure.

• Brand Name: 32MM M2A MOD HEAD STD 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: 5657995
• MDR Text Key: 45276577
• Report Number: 0001825034-2016-01602
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/29/2012
• Device Model Number: N/A
• Device Catalogue Number: 11-163669
• Device Lot Number: 024600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2002
• 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: 43 YR