MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI; PROSTHESIS, HIP

Catalog Number	110010243
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577); Bursitis (4832); Medical device site infection (4845); Aseptic loosening (4883); Septic loosening (4884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 0100561317, lot: 3122141, wagner cone prosthesis.Cat: 00877503603, lot: 3156929, bioloxâ® delta, ceramic femoral head.Cat: 30103604, lot: 66179347, 36mm i.D.Size d neutral liner.Cat: 00625006520, lot: j7488887, bone screw self-tapping.Cat: 00625006525, lot: j7526159, bone screw self-tapping.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 approximately two years post-implantation, the patient is being considered for a hip revision due to bacterial infection and loosening.Patient reports pain, swelling, and trochanteric bursitis diagnosis.Revision is planned but has not yet taken place.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5; b6; g3; h6 health impact code.The following sections were corrected: h6 clinical codes remove e161202, e2123, and e1901 and add e161201.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 approximately two years post-implantation, the patient is being considered for a hip revision due to loosening with infection unlikely.Patient reports pain, swelling, and trochanteric bursitis diagnosis.Revision is planned.Attempts have been made and no further information has been provided.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.

• Brand Name: G7 OSSEOTI
• 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: 23027057
• Report Number: 0001825034-2025-02881
• Device Sequence Number: 21287122
• Product Code: LPH
• UDI-Device Identifier: 00887868355875
• UDI-Public: (01)00887868355875(17)330704(10)65862844
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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: 110010243
• Device Lot Number: 65862844
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 11/11/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/21/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 82 KG