MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Difficult to Remove (1528)

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

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products: m2a-magnum pf cup 52odx46id cat#us157852 lot#285770, taperloc por fmrl 11x142 cat#103205 lot#528650, m2a-magnum 42-50mm tpr insrt-3 cat#139254 lot#267160.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04793, 0001825034 - 2019 - 04794, 0001825034 - 2019 - 04795.

Event Description

It was reported a patient underwent an initial left tha.Subsequently, the patient was revised approximately 9 years later due to pain and elevated metal ion levels.It was noted the taper was difficult to remove from the stem.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.Reported event was confirmed with medical records provided.Review of revision operative notes state the patient was revised due to pain, elevated ion levels and altr.Radiographs indicate lucency around the acetabular shell and around the calcar.Difficulty removing the taper from the trunnion.Carbide bur was used to release it.Minor damage to the trunnion.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.

Event Description

No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM MOD HD SZ 46MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9225147
• MDR Text Key: 164813945
• Report Number: 0001825034-2019-04797
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 179540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• 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