MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TISSUE SPARING FEM CORE BASE 1; HIP INSTRUMENTS : INSTRUMENT CASES

Catalog Number 259807400

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: examination of the returned device found material to be delaminating from device.The root cause is attributed to heavy usage and wear out.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

It was reported that the trilock total hip instrument trays were beginning to show wear and break down on the rubberized inside pieces.Hospital requested that the trays be replaced with new ones.This does not include any instrumentation, just the sterilization trays.No report of harm or delay.

• Brand Name: TISSUE SPARING FEM CORE BASE 1
• Type of Device: HIP INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8927514
• MDR Text Key: 161253140
• Report Number: 1818910-2019-102104
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295148340
• UDI-Public: 10603295148340
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 259807400
• Device Lot Number: CF6MB4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR