MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6; HIP PROSTHESIS

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

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: item # (b)(4), magnum trispike cup, lot # 264460, item #(b)(4), m2a-magnum mod hd, lot # 563840, item #(b)(4), mlry-hd lat por fmrl, lot # 303380.

Event Description

It was reported that the femoral head would not disengage during revision.No impact or harm to patient has been reported.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed by review of medical records, which identified difficulty in removing the femoral head.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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 42-50MM TPR INSRT-6
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8206311
• MDR Text Key: 131722927
• Report Number: 0001825034-2018-11521
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 139252
• Device Lot Number: 920510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 118