MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 48MM C; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown liner unknown.Unknown head unknown.G2: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient had a severe acetabular defect and the plan was to use an acetabular augment to support the shell.During positioning of the definitive tm augment, it was pulled out of the wound and dropped on the floor, deeming it unusable.No other augments from the inventory available were suitable for the defect.As such, the surgeon implanted the cup without an augment.Initial stability was suitable, and the patient was close.The following day, the patient dislocated.It was found that the cup had subsided and dislocated.The patient was brought back to theatre to remove the cup and replace it with a larger size.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-01194.0001825034-2024-01195.This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: severe left hip arthrosis with osseous resorption of the acetabular fossa.Subsequent left hip arthroplasty as noted with dislocation.The reported event was confirmed via medical records.Dhr was reviewed and no discrepancies related to the reported event were found.Implanting the shell without the argument may have caused or contributed to the reported event.A tm augment was initially needed to support the cup, the cup was implanted without the support of the augment which most likely led to the subsequent dislocation.This is considered off-label use per ifu 01-50-1231 page 2 under possible adverse effects " dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions".Additionally the g7 surgical technique 2336.4-glbl page 1 under contraindications "bone or musculature compromised by disease, infection, or prior implantation that cannot provide adequate support or fixation for the prosthesis".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 OSSEOTI MULTIHOLE 48MM C
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19282016
• Report Number: 0001825034-2024-01193
• Device Sequence Number: 20748185
• Product Code: LPH
• UDI-Device Identifier: 00887868356001
• UDI-Public: (01)00887868356001(17)330815(10)65960774
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110010262
• Device Lot Number: 65960774
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 59 KG