MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PIN TRL LNR NEUT 580DX36ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number 221836058

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

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.

Event Description

Surgeon trailed neutral liner.Then removed trial as normal with hex driver and proceeded to impact liner implant into cup.Scrub nurse then noticed the metal ring from the liner trial was missing.Ring potentially in apex hole of cup, behind impacted liner.Surgeon then removed liner implant and ring was there as suspected.Liner now damaged as it had to be removed, so another lipped liner was opened and impacted.10 minute delay to procedure.No ae to patient.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the instrument associated with this report was not returned.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.

• Brand Name: PIN TRL LNR NEUT 580DX36ID
• Type of Device: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8202880
• MDR Text Key: 131620459
• Report Number: 1818910-2018-79376
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295101208
• UDI-Public: 10603295101208
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221836058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Patient Sequence Number: 1