MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 50MM D; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a hip arthroplasty and was implanted with zimmer biomet products.Subsequently, the patient was revised nearly one (1) year post implantation due to dislocation.The liner was explanted.
Additional Manufacturer Narrative
(b)(4).D10: 110024462 g7 dual mobility liner 40mm d 66310817.Ep-200146 act artic e1 hip brg 28x40mm 66202328.Unknown ceramic head.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, g3, g6, h2, h3, h4, h6, h10, h11 visual examination of the provided pictures identified the bearing and head implants covered in bio-debris.No further evaluation could be made from the pictures provided.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.An undated radiograph was provided and not submitted to mmi due to the inability to correlate the image with the allegation.A definitive root cause cannot be determined.Complaint cannot be confirmed.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 trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 50MM D
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22168821
• Report Number: 0001822565-2025-01744
• Device Sequence Number: 18092454
• Product Code: LPH
• UDI-Device Identifier: 00887868355875
• UDI-Public: (01)00887868355875(17)330803(10)7582177
• 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
• 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): 09/10/2025

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 Model Number: N/A
• Device Catalogue Number: 110010243
• Device Lot Number: 7582177
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 58 KG