MAUDE Adverse Event Report: Zimmer Biomet, Inc. G7 SCREW 6.5MM X 40MM; Prosthesis, Hip

Catalog Number	010001001
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Radiolucent Lines (4848)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).\ \ h10:\ g7 screw 6.5mm x 40mm.\ item: 010001001.\ lot: 7155222.\ \ arcos con sz c std 60mm.\ item: 11-301303.\ lot: 65710916.\ \ g7 osseoti multihole 58mm g.\ item: 110010267\ lot: 7196540.\ \ g7 hi-wall e1 liner 36mm g.\ item: 010000937.\ lot: 7210981.\ \ g7 screw 6.5mm x 30mm.\ item: 010000999.\ lot: 7389732.\ \ delta ceramic fem hd 36/-3mm.\ item: 650-0660.\ lot: 3095592.\ \ g2: foreign ¿ australia.\ \ the product was requested but was not returned by the hospital and will therefore not be sent to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately three years post-implantation due to pain and radiolucency of component.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.\ the following sections were updated: g3; h2; h3; h6; h10\ \ visual examination of the provided pictures identified the explanted stem, cone body, head, shell, liner and screw.Devices were covered in bio-debris.No further evaluation could be made with the provided picture.\ \ review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.\ \ radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic radiolucent lines at the acetabular cup metal-bone interface are consistent with loosening.Bony sclerosis is present at the acetabular roof along with bone spurring at the superolateral acetabular roof.The greater trochanter and lesser trochanter are in closer proximity to the bony pelvis than is typical.A small bone island (likely due to heterotopic ossification) resides adjacent to the lesser trochanter.\ \ 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 trends.

• Brand Name: G7 SCREW 6.5MM X 40MM
• Common Device Name: Prosthesis, Hip
• 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 ; +1(574)526-0384
• MDR Report Key: 50542144
• Report Number: 0001825034-2026-02631
• Device Sequence Number: 13341819
• Product Code: LZO
• UDI-Device Identifier: 00880304527492
• UDI-Public: (01)00880304527492(17)320301(10)7207802
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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 Catalogue Number: 010001001
• Device Lot Number: 7207802
• 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: 04/30/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown