MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM SYSTEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Pain (1994); Local Reaction (2035)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned due to product location unknown to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 11-103208 name: taperloc por lat fmrl 15x150 lot: 801650, part: 139266 name: m2a-magnum 52-60 mm tpr insrt-3 lot: 811200, part: 157452 name: m2a-magnum mod hd sz 52 mm lot: 803020.Multiple mdr reports were filed for this event, please see associated reports (reference 0001825034-2017-02356).

Event Description

It was reported that a patients right hip was revised approximately 5 years post implantation due to pain.The head and cup were removed.Signs of metallosis were found during the revision.Evidence of head erosion found as well as signs of adverse local tissue reactions around some of the sclerotic bone in the greater trochanter region.Stress shielding behind the cup was also found.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of op notes.Revision operative findings show surgeon noted the metal tinged fluid with reactive lymphocytes and the capsule was found to be consistent with an acute local tissue reaction secondary to the metallosis, sclerotic bone erosion, and stress shielding behind the cup.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A MAGNUM SYSTEM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6464550
• MDR Text Key: 71895365
• Report Number: 0001825034-2017-02350
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: US157858
• Device Lot Number: 203850
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 10/03/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2010
• 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: 78 YR