MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 12/14 TPR 42-50 +3; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant products: part: us157850, lot: 271310.Part: 157444, lot: 604070.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01828, 0001825034-2021-01829.

Event Description

It was reported that the patient underwent a right hip revision procedure approximately eight years and eight months post-implantation due to pain, difficulty ambulation and increase metal ion levels.The head was replaced.Attempts have been made and no further information has been provided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: M2A-MAGNUM 12/14 TPR 42-50 +3
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12015477
• MDR Text Key: 256692276
• Report Number: 0001825034-2021-01830
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: 239258
• Device Lot Number: 617600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR