MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 48MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Scratched Material (3020)

Patient Problems Debris, Bone Shedding (1803); Pain (1994); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:139256 lot number:83170 brand name : m2a magnum taper insert; catalog number:x12-171310 lot number:465400 brand name : integral femoral stem; catalog number: us157854 lot number: 858440 brand name : m2a magnum cup.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to due to significant pain, tissue destruction , bone destruction, metal wear , limitation of daily activities and metallosis approximately 9 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: M2A-MAGNUM MOD HD SZ 48MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8449103
• MDR Text Key: 139739114
• Report Number: 0001825034-2019-01382
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2019

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: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 157448
• Device Lot Number: 847800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• 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: 68 YR