MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 25MM; PROSTHETIC, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The devices in d10 involve those implanted during the initial procedure.The surgeon is unsure at this time as to which screw actually fractured and therefore the screw remains unknown at this time.D10: 110024468 g7 dual mobility liner 60mm j lot#: 512100 110031020 item name: vivacit-e dm bearing 28x60mm, lot#: 64709980.010000998 item name: g7 screw 6.5mm x 25mm, lot#: 7453205.010000998 item name: g7 screw 6.5mm x 25mm, lot#: 6973105.010000998 item name: g7 screw 6.5mm x 25mm, lot#: 3920103.010000996 item name: g7 screw 6.5mm x 15mm, lot#: 7053137.010000996 item name: g7 screw 6.5mm x 15mm, lot#: 6825841.010000997 item name: g7 screw 6.5mm x 20mm, lot#: 7091303.010000999 item name: g7 screw 6.5mm x 30mm, lot#: 7438777.010000998 item name: g7 screw 6.5mm x 25mm, lot#: 7042299.110010275 item name: g7 osseoti multihole 74mm j, lot#: r3674706a.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01958.The device will not be returned for analysis as it currently remains implanted; 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 remains implanted.

Event Description

It was reported that the patient will undergo a revision in the future due to screw fracture and cup loosening.There is no additional information available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated:.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 d4: (b)(4), expiration: feb 25, 2031.(b)(4), expiration: dec 06, 2026.(b)(4), expiration: jun 16, 2031.(b)(4), expiration: jul 15, 2030.(b)(4), expiration: aug 19, 2031.(b)(4), expiration: jan 30, 2033.(b)(4), expiration: jun 10, 2031.H4: feb 28, 2021; jun 30, 2016; jun 16, 2021; june 31, 2020; aug 19, 2021; jan 30, 2023; jun 10, 2021.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 related to the reported event for the screws.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: G7 SCREW 6.5MM X 25MM
• Type of Device: 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: 17583214
• MDR Text Key: 321518224
• Report Number: 0001825034-2023-01959
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527461
• UDI-Public: (01)00880304527461(17)330220(10)7453205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000998
• Device Lot Number: 7453205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Prefer Not To Disclose