MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 50MM D; PROSTHESIS, HIP

Catalog Number	110010263
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 30123204 lot# 66963690 32mm i.D.Size d high wall liner.Cat# 00625006525 lot# j7633718 bone screw self-tapping 6.5 mm dia.25 mm length.Cat# 00625006515 lot# 64596056 bone screw self-tapping 6.5 mm dia.15 mm length.Cat# 00625006520 lot# j7643022 bone screw self-tapping 6.5 mm dia.20 mm length.Cat# 00625006530 lot# j7900452 bone screw self-tapping 6.5 mm dia.20 mm length.Cat# 00625006515 lot# j7458207 bone screw self-tapping 6.5 mm dia.15 mm length.Cat# 00625006520 lot# j7617986 bone screw self-tapping 6.5 mm dia.20 mm length.Unk head.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately two months later due to dislocation and cup malposition.The cup was retroverted.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Total hip arthroplasty.Acetabular cup abnormal steep lateral angle of inclination is a risk factor for hip dislocation.Cannot exclude loosening of the acetabular cup and osteolysis of the acetabular roof, as reported above.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 further information at the time of this report.

• Brand Name: G7 OSSEOTI MULTIHOLE 50MM D
• 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 ; 5745260384
• MDR Report Key: 23166837
• Report Number: 0001825034-2025-03033
• Device Sequence Number: 13164934
• Product Code: LPH
• UDI-Device Identifier: 00887868356018
• UDI-Public: (01)00887868356018(17)330503(10)7499300
• 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: 2025
• Device Explanted Year: 2025
• 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): 12/23/2025

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: 110010263
• Device Lot Number: 7499300
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG