MAUDE Adverse Event Report: . M2A-MAGNUM 42-50 TPR INSRT STD 0/0MMT1; PROSTHESIS HIP

Catalog Number 139256

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Reaction (2414)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Part # unknown / unknown head / lot # unknown.Part #unknown / unknown cup/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: (b)(4).

Event Description

It was reported that patient underwent right hip revision surgery approximately 9 years post implantation due to severe pain, elevated metal ion levels and metallosis.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.

Event Description

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

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: M2A-MAGNUM 42-50 TPR INSRT STD 0/0MMT1
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11245962
• MDR Text Key: 229298697
• Report Number: 0001825034-2021-00287
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

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: 03/31/2020
• Device Catalogue Number: 139256
• Device Lot Number: 653290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 01/28/2021; 03/17/2021
• Supplement Dates FDA Received: 02/12/2021; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention