MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E HIGH WALL LNR 36MM G; PROSTHESIS, HIP

Catalog Number	30123607
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00086 0001822565-2024-00087 d10: unknown cup cat #: 00784801301 / kinectiv modular neck p1 / lot #: 65438281.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 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).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.
Additional Manufacturer Narrative
(b)(4).Visual examination of the provided pictures identified the explanted liner, with some damage noted around the locking portion.The device is covered in bio debris.No further evaluation can be made from the provided pictures.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a revision occurred approximately two months post implantation to instability, noise, and pain.The head was noted to incongruent/migrated on previous scans.During the revision, the liner was noted to have flipped out of position anteriorly, and the head had a spot of erosion where it was articulating against the shell.Metallosis tissues were noted throughout the joint.The liner, head, and neck were explanted and replaced.The complaint was confirmed based on a review of the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot 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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 VIT E HIGH WALL LNR 36MM G
• 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: 18474779
• Report Number: 0001822565-2024-00085
• Device Sequence Number: 6924178
• 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: K190660
• 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): 05/01/2024

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 Expiration Date: 11/30/2024
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 04/25/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/20/2024; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• 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