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

Catalog Number 00771100610

Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item #: 00620205222, shell, lot #: 61280318.Item #: 00630505036, liner, lot #: 61245220.Item #: 00801803602, head, lot #: 61288475.Item #: 00625006525, bone screw, lot #: 61246396.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 -00774.

Event Description

It was reported that patient underwent right hip revision surgery 10 years post implantation due to pain, pseudotumor and elevated metal ion.During the revision, significant corrosion was observed between the head and neck junction with resultant damage to the surrounding adductors.The head and liner were replaced without complication.Attempts have been made and no additional information is available at this time.

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.Corrected d10: therapy date.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a right hip arthroplasty due to degenerative joint disease.Zimmer biomet components were implanted without any complications.The patient underwent a revision procedure due to failed hip arthroplasty.The patient presented with pain, and elevated metal ions.During the procedure, corrosion was observed at the head-trunnion junction.There was a moderate amount of adductor damage secondary to corrosion and pseudocapsule was debrided.The head and liner were replaced with new zimmer biomet products.No other finding/complication related to the event was noted.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11772994
• MDR Text Key: 250684841
• Report Number: 0001822565-2021-01227
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00889024131675
• UDI-Public: (01)00889024131675
• 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,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 00771100610
• Device Lot Number: 61158129
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 84