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

Model Number N/A

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Local Reaction (2035); Metal Related Pathology (4530)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# 00801803202 femoral head lot# 61331612.Cat# 00630505032 liner standard 32 mm lot# 61308238.Unknown cup.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: 0001822565-2021-01087.

Event Description

It was reported the patient underwent a right hip revision approximately 10 years post implantation due to elevated metal ions, mechanically assisted crevice corrosion, and pseudocapsule.The stem and shell remained intact.The head and liner were exchanged without complication.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records identified the following: the patient underwent an initial right total hip arthroplasty due to dysplasia and severe degenerative arthritis.The patient was revised on due to failed hip arthroplasty.The patient had elevated metal ions in the blood.During the procedure, dark discoloration was observed on the anetrior inferior pseudocapsule.There was dark staining and stamping in the head taper.Poly liner was yellowed and the locking ring moved freely.The head and liner were replaced with new zimmer biomet products.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 STEM 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11688626
• MDR Text Key: 247755782
• Report Number: 0001822565-2021-01113
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00771100900
• Device Lot Number: 61304388
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00620005222 SHELL 61142217; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR