MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 54MM F; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 010000858 g7 neutral e1 liner 36mm f 7665674, 010000858 g7 neutral e1 liner 36mm f 7619683, 010000864 g7 neutral e1 liner 40mm f 6678498.G2: foreign: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during an initial hip arthroplasty, the g7 neutral poly liner would not seat properly within g7 oseoti limited hole shell.The shell had two screws insitu and surgeon tried to seat a 36 neutral poly liner using standard procedure with the straight liner impactor.The surgeon also tried utilizing the smaller impactor sizes to provide more room for the plastic locking ring to engage and it would not seat.The surgeon proceeded to attempt with two more poly liner options, including another 36mm neutral and then a 40mm neutral poly liner.Surgeon determined a fault in the shells locking ring mechanism and proceeded with dual mobility, which then seated instantly.Three liners were discarded in the process.
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 visual examination of the returned products identified that all three liner devices have damage to the scallops.Liner 6678498 has damage to the locking feature of the device.Liner 7665674 has circular indentations to the od of the device.Liner 7619683 has damage to the scallop.The height, diameter, and scallop diameter were checked per the prints with all measurements found within specifications.The shell was not returned for evaluation therefore further visual and dimensional analysis could not be performed.Liners & shell: review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm complaint.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 for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: G7 OSSEOTI 4 HOLE SHELL 54MM F
• Common Device Name: PROSTHESIS, HIPS
• 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: 20560318
• Report Number: 0001825034-2024-02545
• Device Sequence Number: 19602296
• Product Code: LPH
• UDI-Device Identifier: 00887868355899
• UDI-Public: (01)00887868355899(17)340328(10)66506139
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110010245
• Device Lot Number: 66506139
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 82 KG