MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-TAPER LINER SZ 41/32; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Infiltration into Tissue (1931); Pain (1994); Swelling (2091); Tissue Damage (2104); Chemical Exposure (2570); Test Result (2695)

Event Date 05/24/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent total right hip arthroplasty on (b)(6) 2002, and a revision procedure on (b)(6) 2013, due to patient allegations of pain, swelling, elevated metal ions, and metallosis.Legal counsel for patient further reports that fluid, granuale formation, metal staining, soft tissue defect in the lateral hip, atrophy, perivascular lymphocytic infiltration, corrosion of the trunnion, and a pseudotumor were allegedly noted during the revision procedure.A review of invoice history confirmed both surgery dates.Legal counsel reports all components were removed and replaced with competitor product.This report is based on allegations set forth in patient¿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 2 states, ¿early or late postoperative infection and allergic reaction." number 10 states, "fretting and crevice corrosion can occur at interfaces between components." number 14 states, "postoperative bone fracture and pain".Number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is number 3 of 4 mdrs filed for the same event (reference 1825034-2014-02496 / 02499).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Event Description

Legal counsel for patient reported that patient underwent total right hip arthroplasty on (b)(6) 2002, and a revision procedure on (b)(6) 2013, due to patient allegations of pain, swelling, elevated metal ions, and metallosis.Legal counsel for patient further reports that fluid, granuale formation, metal staining, soft tissue defect in the lateral hip, atrophy, perivascular lymphocitc infiltration, corrosion of the trunnion, and a pseudotumor were allegedly noted during the revision procedure.A review of invoice history confirmed both surgery dates.Legal counsel reports all components were removed and replaced with competitor product.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Operative report received noted patient underwent a right hip revision on (b)(6) 2013 due to cup malposition, chronic trochantic bursitis and fluid collection.Revision operative report noted the presence of fluid, metal staining, soft tissue defect, short rotator deficiency, abductor musculature with fraying fibers and metal staining, granulation tissue, perivascular lymphocytic infiltration, flaky corrosion at the trunnion and a pseudotumor.The stem remained implanted.The acetabular cup, taper liner and modular head were removed and replaced with a competitor's acetabular cup and biomet head.

• Brand Name: M2A-TAPER LINER SZ 41/32
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3728381
• MDR Text Key: 16223322
• Report Number: 0001825034-2014-02496
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 15-105004
• Device Lot Number: 507270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2002
• 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: 77 YR