MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 38MM MOD HD -6MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Reaction (2414)

Event Date 07/14/2015

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 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Product location unknown.

Event Description

Legal counsel for patient reported that patient underwent a left hip revision procedure approximately eight years post-implantation.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Medical records report patient experienced pain in the left hip approximately eight years post-implantation.Review of invoice history shows the modular head was removed and replaced during the revision procedure.

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 10 states, ¿fretting and crevice corrosion may occur at interfaces between components.¿ this report is number 1 of 3 mdrs filed for the same patient (reference 1825034-2016-03581 & 04029 / 04030).

Event Description

Legal counsel for patient reported that patient underwent a left hip revision procedure approximately eight years post-implantation.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.It was reported in medical records received that patient underwent a left hip revision procedure approximately eight years post-implantation due to pseudotumor formation, lateralization of the cup and the insert being offset.During the procedure, clear fluid, debris, necrotic tissue and trunnionosis with black fluid were noted.The cup, liner and head were removed and replaced.A legacy zimmer liner and cup were used to complete the procedure.

• Brand Name: M2A 38MM MOD HD -6MM 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: 5940535
• MDR Text Key: 54393769
• Report Number: 0001825034-2016-03581
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• 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: 09/09/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-173660
• Device Lot Number: 261860
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2006
• 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: 69 YR