MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FINNED 4 HOLE SHELL 56F; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 30124006 65003239 g7 vit e high wall lnr 40mm f, 802804004 3045483 femoral head type 1 taper 40 mm diameter +6 mm neck length, 00625006535 j7105893 bone scr 6.5x35 self-tap, 00625006535 j6852517 bone scr 6.5x35 self-tap, unknown stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was not released by the hospital.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 patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 4 months post implantation due to reoccurring dislocations.The head and liner were revised as well as the cup to add anteversion.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 reported event was unable to be confirmed due to limited information received from the customer.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined, however, it was noted that the surgeon revised the cup to add anteversion.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 further event information available at the time of this report.

• Brand Name: G7 FINNED 4 HOLE SHELL 56F
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13901595
• Report Number: 0001825034-2022-00689
• Device Sequence Number: 4240618
• Product Code: OQG
• UDI-Device Identifier: 00880304672123
• UDI-Public: (01)00880304672123(17)310519(10)7016877
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 04/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110017105
• Device Lot Number: 7016877
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male