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

Catalog Number	00771100610
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11772994
• Report Number: 0001822565-2021-01227
• Device Sequence Number: 4244581
• Product Code: MEH
• UDI-Device Identifier: 00889024131675
• UDI-Public: (01)00889024131675
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 84