MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Pain (1994); Tissue Damage (2104); Reaction (2414); No Information (3190)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown-m2a stem-unknown.Unknown-m2a cup-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01749.0001825034 - 2020 - 01751.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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.Product location unknown.

Event Description

It was reported the patient is experiencing unknown issues.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: us257856- magnum trispike cup 56odx50id- 003930 139252- m2a-magnum 42-50mm tpr insrt-6- 621320 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a revision surgery 9 years post implantation due to metallosis and metal related pathology.During the procedure pseudotumor encountered and extreme pressure upon opening that released fluid, entire abductor detached, gray debris present, extensive reconstruction to tendon performed.Cyst in the lateral greater trochanter, bone graft is used to fill the area.Gray tan debris on femoral head noted.Cup and stem retained.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed via review of medical records and radiographs by a health care professional.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 MOD HD SZ 50MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9986132
• MDR Text Key: 188523257
• Report Number: 0001825034-2020-01750
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2020

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: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 040400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 04/24/2020; 08/17/2020
• Supplement Dates FDA Received: 05/11/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.; SEE H10.
• Patient Outcome(s): Hospitalization; Other; Required Intervention