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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Concomitant: 0100001003, cls dbl ofs rasp hdl lt, 11682241; 780038, ball-head impactor attachment, 11682241.(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.

Event Description

It was reported that the provisional head was stuck on the definitive stem in the patient.No harm came to the patient.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.A 40mm versys femoral head provisional was returned for evaluation.As returned, damage is seen in the conical taper, outer sphere, and bottom surface.Damage is too severe for dimensional analysis.Device history record 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: FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER
• 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: 7106307
• MDR Text Key: 94823963
• Report Number: 0001822565-2017-08363
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PN/A
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• 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: 00789504001
• Device Lot Number: 61867168
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2011
• 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