MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 30MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 110010269 g7 osseoti multihole 62mm h 66269346.Unknown screw unknown.Unknown screw unknown.G2: foreign: switzerland.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent an initial hip arthroplasty.Subsequently, the patient is being revised three months post implantation due to implant loosening.It was reported that the multihole dm was implanted with a gap in the anterior cranial.The gap was filled with bone substitute and 3 screws.The bone substitute was not stable enough resulting in loosening of the screws followed by pushing out the dual mobility liner.The liner was loose in the cup resulting in metal abrasion of internal cup rim.The acetabular component, liner, and screws were exchanged.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d1, d2, d4, g3, g4, g6, h2.
Event or Problem Description
No additional event information to report at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The screws weren't returned so no evaluation could be complete.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: interval revision surgery for a right total hip arthroplasty with acetabular cup liner replacement.The root cause of the reported issue is attributed to off-label use, a tm augment was initially needed to support the cup, the cup was implanted without the support of the augment which led to the subsequent loose screws and the disassociation of the liner from the cup.This is considered off-label 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, 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 SCREW 6.5MM X 30MM
• 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: 19360164
• Report Number: 0001825034-2024-01309
• Device Sequence Number: 6342425
• Product Code: PBI
• UDI-Device Identifier: 00880304527478
• UDI-Public: (01)00880304527478(17)291120(10)6685697
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121874
• 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,Followup
• Report Date (Section B): 10/10/2024
• 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 Model Number: N/A
• Device Catalogue Number: 010000999
• Device Lot Number: 6685697
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 10/09/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/25/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown