MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 48 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00632004832, xlpe liner, 62082515, 00877503201, bioloxâ® delta ceramic femoral head, 2678778.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001822565 - 2018 - 02279.Requested but not returned by hospital.

Event Description

It was reported that a patient underwent an initial left hip procedure.Subsequently, the patient was revised due to wear.A portion of the shell above the locking ring tabs was found broken.This allowed the liner to move, and some of the elevated portion of the liner was broken as well.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional: updated reported event was confirmed by review of x-rays provided.X-ray review; no fracture can be identified, as no displaced fracture is identified.If there is a nondisplaced fracture, this cannot be excluded.Minimal eccentric positioning of the left femoral head with respect to the cup can be seen in the setting of liner malfunction, as suggested in the provided complaint.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: SHELL POROUS WITH CLUSTER HOLES 48 MM
• 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: 7458451
• MDR Text Key: 106435666
• Report Number: 0001822565-2018-02278
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00620204822
• Device Lot Number: 62283425
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR