MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MODULAR HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2017

Event Type  malfunction  

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.Concomitant medical products: part: 157450, m2a-magnum mod hd sz 50mm, lot: 838780.Part: 139252, m2a-magnum 42-50mm tpr insrt-6, lot: 094660.Part: us157856, m2a-magnum pf cup 56odx50id, lot: 675670.Part: 11-103205, taperloc por lat fmrl 11x142, lot: 916780.Multiple mdr reports were filed for this event, please see associated reports: head: 0001825034-2019-03246, taper: 0001825034-2019-03244.

Event Description

It was reported that the patient underwent an initial left total hip arthroplasty and subsequently, the patient was revised six and a half years later.During the revision procedure, it was noted that the connection sleeve was cold-welded to the stem taper.Attempts have been made and no further information has been provided.

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.

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.

• Brand Name: M2A-MAGNUM MODULAR HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8835942
• MDR Text Key: 152917419
• Report Number: 0001825034-2019-03246
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 838780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1