MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM TAPER ADAPTER 42-50MM -3MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problems Reaction (2414); No Code Available (3191)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation of the reported event is in progress.Once the investigation is completed, a supplemental med watch 3500a will be submitted.Concomitant medical devices: m2a-magnum mod hd sz 44mm item# 157444 lot# 592350; medical device:m2a-magnum 42-50mm tpr insrt-3 item#139254 lot#394350; medical device: us 257850 lot # 336940.

Event Description

It was reported that during a hip revision procedure, surgeon did not have appropriate tool to remove components and the revision was unable to be completed.Revision will take place at a later date.Attempts have been made and all available information has been obtained.No additional patient consequences were reported.No components were removed during this procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by additional follow up information which confirmed that the removal tool was not available.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: M2A-MAGNUM TAPER ADAPTER 42-50MM -3MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7346325
• MDR Text Key: 102713028
• Report Number: 0001825034-2018-01914
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 139254
• Device Lot Number: 394350
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR