MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER FEMORAL HEAD PROVISIONAL; HIP INSTRUMENTATION

Model Number N/A

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

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

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 00780501100 neck provisional lot # 63279318.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-00796, 00797.

Event Description

It was reported that the surgeon was attempting to dislocate hip without success during an initial surgery.The femoral head and neck trials would not disengage.The surgeon then used an osteotome to break the femoral head and neck trials apart.All broken pieces were accounted for, and some of the pieces were thrown away by hospital.Attempts have been made, and further information has been provided.

Manufacturer Narrative

This report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed the devices were returned to the manufacturer for evaluation.Both devices were returned fractured.Damage is too severe for accurate dimensional analysis.Both devices exhibit wear and gouges.Device history record (dhr) was reviewed and no discrepancies were found.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: ZIMMER FEMORAL HEAD PROVISIONAL
• Type of Device: HIP INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7269302
• MDR Text Key: 100270255
• Report Number: 0001822565-2018-00797
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00789503202
• Device Lot Number: 61986916
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Date Manufacturer Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1