MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER +3.5 MM NECK LENGTH 28 MM DIAMETER; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Separation Problem (4043)

Patient Problem Death (1802)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the trial head came off of the trial neck and fell into the anterior ilium.There was a 60 min delay in the procedure.Additional incision were made to remove the trial component.It was reported that the patient expired one day post operatively.Attempts have been made and additional information on the reported event is unavailable.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: date of report, event, pma/510k, if follow-up, what type, device evaluated by mfr, device manufacture date.The following section has been corrected: device code.Reported event was unable to be confirmed.A femoral head provisional 12/14 was returned.Visual examination identified gouges and scratches, consistent with use, on the taper and the outer spherical surface.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER +3.5 MM NECK LENGTH 28 MM DIAMETER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8312755
• MDR Text Key: 135238443
• Report Number: 0001822565-2019-00439
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00789502803
• Device Lot Number: 62631661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention