MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI-DBLE LEAD CORT 5.0X80MM SCR IA5.0X80MM; PROSTHESIS, SHOULDER

Catalog Number	14-405080
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).6 ti-dble screw product indentifcations were reported in conjunction with this event.It is unknown after follow-up attempts which device has migrated.The information for the other screws is as follows: item name: ti-dble lead cort 5.0x60mm scr ia5.0x60mm.Cat#: 14-405060.Lot#: 043360.Expiration date: 9/30/19.Manufacture date: 9/30/29.Item name: ti-dble lead cort 5.0x60mm scr ia5.0x60mm.Cat#: 14-405060.Lot#: 907430.Expiration date: 10/10/19.Manufacture date: 10/10/29.Item name:ti-dble lead cort 5.0x70mm scr ia5.0x70mm.Cat#: 14-405070.Lot#: 423340.Expiration date: 1/27/20.Manufacture date: 1/27/30.Item name:ti-dble lead cort 5.0x34mm scr ia5.0x34mm.Cat#: 14-405034.Lot#: 662780.Expiration date.Manufacture date.Item name: ti-dble lead cort 5.0x34mm scr ia5.0x34mm.Cat#: 14-405034.Lot#: 662780.Expiration date.Manufacture date.Fem nail retro 12mm x 340mm mm x 34cm cat# 14-444334 lot#172100.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient¿s most distal screw was noticed to have backed out of a nail during a patient followup approximately 4 months postimplantation.No further intervention has been reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
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.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: most distal screw in the distal femur appears backed out and extends lateral to the lateral cortex of the lateral femoral condyle.Remaining screws appear appropriately positioned.There is an incompletely healed fracture of distal femur and medial femoral condyle.Remaining bones and hardware appear intact.Backing of the screws confirmed.No contributing factors are noted radiographically.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: TI-DBLE LEAD CORT 5.0X80MM SCR IA5.0X80MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11495106
• Report Number: 0001825034-2021-00716
• Device Sequence Number: 19578041
• Product Code: HSB
• UDI-Device Identifier: 00887868092732
• UDI-Public: (01)00887868092732(17)291002(10)816880
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K063570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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 Catalogue Number: 14-405080
• Device Lot Number: 816880
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other