MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN EXTRACTOR; INSTRUMENT, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: us157854, m2a-magnum pf cup 54odx48id, , 346150; 157448, m2a-magnum mod hd sz 48mm, 651280; 139258, m2a-magnum 42-50m tpr insrt +3, 91910; 14-103203, taperloc microp fmrl 9.0mm, 625730.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08980.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product location unknown].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the revision procedure, the surgeon removed all of the prior components but had difficulty removing the stem.It was stated that the instrument would not thread into the implant, which contributed to the difficulty removing the stem resulting in the fracture her proximal right femur.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Revision notes state that there was difficulty threading the extractor into the implant.When a trial extraction was performed, it was unsuccessful and it was immediately noted that there was an insufficiency of bone along the medical calcar.There was disruption of the anterior bone upon the stem removal, and the femoral fracture was thus stabilized with cables.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause remains undetermined.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: UNKNOWN EXTRACTOR
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8432149
• MDR Text Key: 139429238
• Report Number: 0001825034-2019-01254
• Device Sequence Number: 0
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1