MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 52MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Separation Failure (2547); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 12/28/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: m2a-magnum 52-60mm tpr insrt-3, pn 139266, ln 068770, m2a-magnum pf cup 58odx52id, pn us157858, ln 722540, taperloc por fmrl 15x150, pn 103208, ln 301550.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00102, 0001825034-2020-00103.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial surgery and began experiencing pain and squeaking of the hip as well as elevated ion levels.Revision of the hip was attempted approximately 8 years after the initial surgery, but the head could not be removed.The surgery was aborted and the implant was retained.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Primary right tha performed.Patient subsequently developed elevated metal ions and noise.Attempted revision procedure occurred 9 years later, and unable to disengage femoral head, surgical procedure was aborted and surgical site was irrigated and closed.Approximately 1 week post aborted procedure, patient developed fever and superficial surgical site infection.I&d of surgical site performed 9 days later, no components removed.Patient received iv antibiotic treatment.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this report number.This report should be voided and a corrected report will be filed under report number 0001825034-2020-00104.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this report number.This report should be voided and a corrected report will be filed under report number 0001825034-2020-00104.

• Brand Name: M2A-MAGNUM MOD HD SZ 52MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9563790
• MDR Text Key: 174167633
• Report Number: 0001825034-2020-00101
• Device Sequence Number: 1
• Product Code: KWY
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 157452
• Device Lot Number: 101240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 113