MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK INSERTION DEVICE; HIP INSTRUMENTS

Catalog Number UNK INSERTION DEVICE

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

Patient Problem Pain (1994)

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.During the investigation, a fractured threaded tip of an inserter and/or extractor tool was found retained within the insertion/extraction feature of (b)(4) (stem).The fractured inserter was not included on the initial report.Investigation summary: a fractured tip of an unknown instrument was returned for examination.Per a depuy metallurgist, no material or manufacturing defects that could have contributed to the failure of this instrument were observed.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.

Event Description

Legal notice received that patient underwent corail hip revision.Initial surgery in 2017.

• Brand Name: UNK INSERTION DEVICE
• Type of Device: HIP INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13719967
• MDR Text Key: 286931796
• Report Number: 1818910-2022-04386
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK INSERTION DEVICE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 32 +13 BLK; CORAIL2 STD SIZE 18; PINN MAR LIP LNR 32IDX56OD; PINNACLE MULTIHOLE II CUP 56MM
• Patient Sex: Male