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
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
(b)(4).H10: g7 screw 6.5mm x 40mm, item: 010001001, lot: 7207802, 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.

• 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: 50542129
• Report Number: 0001825034-2026-02630
• Device Sequence Number: 18788885
• Product Code: LZO
• UDI-Device Identifier: 00880304527492
• UDI-Public: (01)00880304527492(17)311129(10)7155222
• 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: 7155222
• 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: 11/29/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown