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

Model Number	N/A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# 30123203 lot# 66484387 32mm i.D.Size c high wall liner cat# 30123203 lot# 65889222 32mm i.D.Size c high wall liner cat# 30123204 lot# 65588016 32mm i.D.Size d high wall liner cat# 30123204 lot# 65781505 32mm i.D.Size d high wall liner g2: foreign ¿ japan.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.
Event or Problem Description
It was reported that during an initial hip procedure, the shell was inserted and the liner could not be inserted.The attempt was made to insert a second liner, which could also not be inserted.A second shell was inserted.The attempt was made to insert two new liners and both could not be inserted.A third liner was able to inserted into the shell to complete the surgery.The surgeon reported that the shell was not stable during liner insertion due to fragile bone quality.There was a 10-15 minute delay to surgery.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6 the second shell was not returned as it was implanted.A review of the device history records identified no related deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.Event cannot be confirmed.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.
Additional Manufacturer Narrative
(b)(4).Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial hip procedure, the shell was inserted and the liner could not be inserted.The attempt was made to insert a second liner, which could also not be inserted.A second shell was inserted.The attempt was made to insert two new liners and both could not be inserted.A third liner was able to inserted into the shell to complete the surgery.The surgeon reported that the shell was not stable during liner insertion due to fragile bone quality.The surgeon used screws to fix the unstable cup.There was a 10-15 minute delay to surgery.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

• Brand Name: G7 ACETABULAR SYSTEM 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: 19547924
• Report Number: 0001825034-2024-01624
• Device Sequence Number: 20534568
• Product Code: LPH
• UDI-Device Identifier: 00887868355875
• UDI-Public: (01)00887868355875(17)331219(10)66363486
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 11/12/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010243
• Device Lot Number: 66363486
• 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: 05/27/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 11/08/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 10/29/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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
• Patient Sex: Unknown