MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER; INSTRUMENT, HIP

Model Number N/A

Device Problems Disassembly (1168); Difficult to Insert (1316)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Concomitant: 00785001300, versys advocate femoral stem, 62955177.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2017 - 00724.

Event Description

It was reported that when the surgeon was trying to pull off the head provisional from the stem the stem came out of the femur.The surgery was finished with a backup stem.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.A versys advocate femoral stem and a versys femoral head provisional were returned for evaluation.As returned, the stem is in excellent condition and shows no signs of damage to the taper.The femoral head provisional exhibits damage to the outer sphere and conical taper.Damage is too severe for dimensional analysis.Review of the device history record identified no deviations or anomalies would contribute to reported event.A definitive root cause cannot 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: FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER
• Type of Device: INSTRUMENT, 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: 7064888
• MDR Text Key: 93561267
• Report Number: 0001822565-2017-08094
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00789502602
• Device Lot Number: 60325007
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention