MAUDE Adverse Event Report: ZIMMER GMBH G7 VIT E HIGH WALL LNR 36MM G; VIVACIT HIP IMPLANT

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Noise, Audible (3273); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 36mm i.D.Size g high wall liner item # 30123607 lot #64591563 modular neck p1 12/14 neck taper use with +0 heads only item #00784801301 lot #65438281 unknown cup item #unknown cup item and lot #unknown.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.
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.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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 and a liner disassociation from cup was noted.The head, neck, and liner were exchanged without complications.The stem and cup remain implanted.Due diligence is complete for this complaint; to date, the product has not been received and no additional information is required.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b5; g3; h2; h3; h6;d10.Corrected: d1;d2; d3, d4 ;h4.Upon reassessment of the reported event, it was determined that this event was reported on mdr360586 (0001822565 - 2024 - 00085 - 2).The initial report was forwarded in error and should be voided.

• Brand Name: G7 VIT E HIGH WALL LNR 36MM G
• Common Device Name: VIVACIT HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18778981
• Report Number: 0009613350-2024-00057
• Device Sequence Number: 14228571
• Product Code: LPH
• UDI-Device Identifier: 00889024520509
• UDI-Public: (01)00889024520509(17)241130(10)64591563
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• 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
• Report Date (Section B): 05/15/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 30123607
• Device Lot Number: 64591563
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2019
• 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
• 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: 00877503602 BIOLOX HEAD LOT 3157992; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 121 KG