MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER STANDARD NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Discomfort (2330); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); No Information (3190)

Event Date 12/08/2014

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.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Event Description

Patient's legal counsel reported patient underwent right hip revision procedure approximately five years post-implantation due to unspecified allegations.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

(b)(4).This follow up report is being submitted to relay additional information.Concomitant products- part: us157844 name:m2a-magnum pf cup 44odx38id lot: 269730 part: 14-103200 name:micro taperloc std pc 5mm t1 lot: 847320.

Event Description

It was reported that a patient was revised approximately 5 years post-implantation due to pain, discomfort, and lack of mobility.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient was revised approximately 5 years post-implantation due to pain, discomfort, lack of mobility, tissue and bone destruction, metal wear, and metal poisoning.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

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

• Brand Name: M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER STANDARD NECK
• 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: 5999493
• MDR Text Key: 56453231
• Report Number: 0001825034-2016-03957
• 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: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-173662
• Device Lot Number: 942730
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2008
• 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: 53 YR