MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ML TAPER SZ15.0 EXT OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Ossification (1428); Failure of Implant (1924); Necrosis (1971); Pain (1994); Metal Related Pathology (4530)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: ref 00-6200-062-22 lot 62530017 trilogy 62mm shell ; ref 00-6310-062-36 lot 62348161 liner ; ref 00-6250-065-30 lot 62640335 screw; ref 00-6250-065-25 lot 62653401 screw ; ref 00-8018-036-02 lot 62561477 versys head.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.

Event Description

It was reported the patient underwent a left hip revision approximately 6 years post implantation due to pain, crevice corrosion, trunnionosis, metallosis, and pseudotumor formation.During the revision, heterotopic ossification and necrotic tissue was debrided.The head and liner were exchanged without complication.No additional information.

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.Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha.The patient was then revised due to pain.Within the joint corrosion, trunnionosis, and a pseudotumor was found.The heterotopic ossification was excised and the poly showed evidence of oxidation.The shell was well fixed, and the liner and head were replaced with zimmer products without complication.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: ML TAPER SZ15.0 EXT OFFSET
• 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 ; .; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12615354
• MDR Text Key: 275898567
• Report Number: 0001822565-2021-02916
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00771101520
• Device Lot Number: 62578066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2014
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male