MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL - GREEN LEFT 10 MM DIAMETER 34 CM LENGTH; FIXATION

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 47248309560, 6.0 mm diameter cancellous screw, lot # 64543973.Catalog #: 47248310060, 6.0 mm diameter cancellous screw, lot # 62803102.Catalog #: 47248403550, 5.0 mm diameter cortical screw, lot # 64917325.Catalog #: 47248404050, 5.0 mm diameter cortical screw, lot # 64875678.Catalog #: 47248403750, 5.0 mm diameter cortical screw, lot # 64358209.Catalog #: 47248700110, antegrade femoral nail cap 10 mm height, lot # 63978732.Catalog #: 47249234110, greater trochanter femoral nail, lot # 64578370.Report source: (b)(6).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient when through an initial operation approximately 7 months ago.The patient had a feeling of strangeness in his left leg 3 months after.The patient went to the hospital and the surgeon confirmed through x-rays that the distal screw was gradually backed out from the implanted position.Therefore only the screw was explanted.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was identified that this device did not cause or contribute to the reported event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: GREATER TROCHANTER FEMORAL NAIL - GREEN LEFT 10 MM DIAMETER 34 CM LENGTH
• Common Device Name: FIXATION
• 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: 12782623
• Report Number: 0001822565-2021-03261
• Device Sequence Number: 19759967
• Product Code: HSB
• UDI-Device Identifier: 00889024096011
• UDI-Public: (01)00889024096011(17)291130(10)64578370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 03/15/2022

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: 47249234110
• Device Lot Number: 64578370
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male