MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE; PROSTHESIS HIP

Catalog Number	00801803602
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); Insufficient Information (4580)
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 # 00771100610/stem/lot # 61158129.Item # 00625006525/ bone screw/lot # 61246396.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00772, 0001822565-2021-00773.
Event or Problem Description
It was reported that patient underwent right hip revision procedure approximately 10 years post implantation due to unknown reasons.Head, cup and liner were revised attempts have been made and additional information on the reported event is unavailable at this time.
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.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920.

• Brand Name: FEMORAL HEAD STERILE
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11528880
• Report Number: 0001822565-2021-00774
• Device Sequence Number: 3945085
• Product Code: LPH
• UDI-Device Identifier: 00889024144729
• UDI-Public: (01)00889024144729
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• 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,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 Catalogue Number: 00801803602
• Device Lot Number: 61288475
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/23/2021; 04/23/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/04/2021; 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 84