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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 05/09/2016

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.Concomitant medical products: item number: 11-103204, item name: taperloc femoral stem, lot #: 886630, item number: 157444, item name: m2a magnum head, lot #: 790140.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03152.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the taper adaptor would not disengage from the trunnion.An extended trochanteric osteotomy was required in order to explant the head and stem.No additional information is available at this time.

Manufacturer Narrative

Reported event was confirmed by review of op notes which indicated the head was unable to be disimpacted from the stem, as it appeared to frozen on to the trunnion.Surgeon then elected to proceed with removal of the stem on block.A trochanteric osteotomy was then planned.Device history record (dhr) was reviewed and no discrepancies 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 42-50 TPR INSRT STD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8821204
• MDR Text Key: 152021622
• Report Number: 0001825034-2019-03153
• 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,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 026930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention