MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A HI CARBON HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Toxicity (2333); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial right total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2015 due to pain and metallosis.The modular head, acetabular cup and liner 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 or deviation.There are warnings in the package insert that state that this type of event can occur: "particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid.It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant." "postoperative bone fracture and pain." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-02293 & 02387).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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 10 states, "fretting and crevice corrosion can occur at interfaces between components." number 11 states, "wear and/or deformation of articulating surfaces." number 14 states, "postoperative bone fracture and pain." number 15 states, "metal on metal articulating surfaces have limited clinical history.Although mechanical testing demonstrates that metal on metal articulating surfaces produce a relatively low amount of particles, the total amount of particulate produced remains undetermined.Because of the limited clinical and preclinical experience, the longterm biological effects of the particulate are unknown." this report is number 2 of 3 mdrs filed for the same patient (reference 1825034-2015-02293 / 2015-02387 / 2016-01721).Not returned by patient.

Event Description

It was reported that patient underwent a right hip revision procedure approximately eight (8) years post-implantation due to pain and metallosis.During the procedure, the modular head, acetabular cup and liner were removed and replaced.Additional information was received from patient's legal counsel alleging the revision procedure was due to pain, metallosis, limited mobility, corrosion, friction wear, metal debris and elevated metal ion levels.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.

Event Description

It was reported that patient underwent a right hip revision procedure approximately eight (8) years post-implantation due to pain and metallosis.Operative report noted soft tissue reaction that created bowel problems.During the procedure, the modular head, acetabular cup and liner were removed and replaced.Patient's legal counsel reported that patient underwent a right hip revision procedure approximately eight (8) years post-implantation due to allegations of pain, metallosis, limited mobility, corrosion, friction wear, metal poisoning, metal debris and elevated metal ion levels.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

• Brand Name: 32MM M2A HI CARBON HD 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: 4812282
• MDR Text Key: 20771939
• Report Number: 0001825034-2015-02387
• 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: Company Representative,company representative
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2016

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: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 11-163688
• Device Lot Number: 901930
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/25/2016; 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2007
• 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: 74 YR