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

Catalog Number	110010243
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an initial left total hip arthroplasty.At 2 years postop, the patient reports ongoing moderate low back pain that was not present prior to the initial procedure.It was initially thought to be general postop soreness, but the pain has not resolved and continues to limit daily activities.The patient has started therapy for the low back pain, takes nsaids for pain, and uses a cane for long distances.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).A2: dob: (b)(6).D10: cat# 650-1158 lot# 3137152 delta cer fem hd 28/0mm t1.Cat# 00625006525 lot# j7381512 bone screw self-tapping 6.5 mm dia.25 mm length.Cat# 110031010 lot# 65754279 28mm i.D.40mm o.D.Size d bearing.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 information.The following sections were {update/corrected}.Updated: g3; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: 6 weeks postop slight pain/problems, slight limp, cane for long walks; 1 year postop slight pain/problems, prn nsaids for pain, no limp, cane for long walks ¿moderate pain that requires pain medicine stronger than aspirin/similar medication.; ae ¿subject states she has had low back pain since her surgery.She did not have this prior to surgery.Initially thought it was general postop soreness.It has not gone away and continues to limit activities.¿ pt treatment, event ongoing and not resolved.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 ACETABULAR SHELL 3 HOLE 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: 22284953
• Report Number: 0001825034-2025-01781
• Device Sequence Number: 20914762
• Product Code: LPH
• UDI-Device Identifier: 00880304544185
• UDI-Public: (01)00880304544185(17)321212(10)65566556
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110010243
• Device Lot Number: 65566556
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 83 KG