MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E; PROSTHETIC, HIP

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	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw went through the hole of the cup and ended up on the other side of the cup.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02302.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 d1 d4: catalog and lot d10 00-6250-065-30 trilogy bone scr 6.5x30 lot number j7393433 g3 g4: pma/510(k) number g6 h2 h10.
Event or Problem Description
There is no update to the prior event description provided.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the incompletely visualized left hip arthroplasty.Single surgical screw within the acetabulum without fixation as noted.The root cause of the reported issue is attributed to user error, as the incorrect drill guide was used to place the screw.The gold drill guide should be used when placing screws with the g7 shells.This complaint was confirmed based on provided x-rays.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 52MM E
• Common Device Name: PROSTHETIC, 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: 17885592
• Report Number: 0001825034-2023-02303
• Device Sequence Number: 12506588
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)330504(10)7506442
• 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: 2023
• 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): 01/26/2024

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: 110010244
• Device Lot Number: 7506442
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 10/07/2023; 01/26/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/11/2023; 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10.; UNKNOWN SCREW.
• Patient Sex: Male