MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KINECTIV MODULAR NECK P1; PROSTHESIS, HIP

Catalog Number	00784801301
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a left hip revision approximately eleven weeks post implantation due to a disassociation of the liner and cup.During the procedure, metalosis was noted from the head rubbing on the cup.All the metalosis was removed and the liner, head and neck were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00085, 0001822565-2024-00086.D10: cat #: 30123607 / g7 vit e high wall lnr 36mm g/ lot #: 64591563.Unknown cup.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined to be not reportable as this product did not cause or contribute to the event.The initial report should be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable as this product did not cause or contribute to the event.The initial report should be voided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10: additional item: cat#: 00877503602 / biolox delta head 12/14 36x0 / lot#: 3157992.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that a patient underwent a left hip revision approximately two months post implantation due to instability, pain, squeaking, popping, and stiffness.Radiographic images indicated migration of head.During the revision, when the head was removed, metallosis and erosion were noted.The head, neck, and liner were exchanged without complications.The stem and cup remain implanted.

• Brand Name: KINECTIV MODULAR NECK P1
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18474769
• Report Number: 0001822565-2024-00087
• Device Sequence Number: 17873433
• Product Code: LPH
• UDI-Device Identifier: 00889024509467
• UDI-Public: (01)00889024509467(17)320317(10)65438281
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2024

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: 00784801301
• Device Lot Number: 65438281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 04/15/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/20/2024; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 121 KG