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

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 110003451 item name g7 str modular shell inserter lot # 020510 multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2023 - 02990.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.H3 other text : device in process to return.
Event or Problem Description
It was reported that the g7 straight cup inserter wouldn¿t disengage from the cup.The surgeon broke the hex head driver off and had to pull a good seated cup out of patients pelvis.The tech couldn¿t get the cup disengaged from the underside with the screw driver.After the case was able to get the cup disengage in the spd area.No pieces fell in the patient and the procedure was completed using another device.There is no additional information available at the time of this report.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint as no product was returned, images provided, or medical records were provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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.

• 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: 18344732
• Report Number: 0001825034-2023-02991
• Device Sequence Number: 6221912
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)330920(10)66018387
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 66018387
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Male