MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 5.5X25MM GRIPTION TF STE SCREW; GRIPTION TF AUGMENT : HIP METAL ACETABULAR CUPS

Model Number 1217-25-800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hip Fracture (2349); No Code Available (3191)

Event Date 12/29/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records, it was reported that the patient got up out of bed and tore the acetabular component out, fractured around it.Then the patient was revised for displaced left acetabular component/ periprosthetic fracture.Operative notes reported that about 300 ml hematoma was expelled.The constrained liner was still locked around the prosthetic ball but it had torn the shell out of her native acetabular fossa.Screws has been added to the complaint.Doi: (b)(6) 2017; dor: (b)(6) 2017; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5X25MM GRIPTION TF STE SCREW
• Type of Device: GRIPTION TF AUGMENT : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9756423
• MDR Text Key: 181935334
• Report Number: 1818910-2020-06021
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295381365
• UDI-Public: 10603295381365
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 1217-25-800
• Device Catalogue Number: 121725800
• Device Lot Number: 477978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR