MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE REV FEM TRL R STD; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number 229428040

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

Event Description

It was reported that the two trials is no longer possible to disconnect.No surgery prolongation, no adverse consequences for patient.

Manufacturer Narrative

Product complaint # (b)(4) investigation summary: examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: LCS COMPLETE REV FEM TRL R STD
• Type of Device: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7952016
• MDR Text Key: 123255943
• Report Number: 1818910-2018-71977
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295113041
• UDI-Public: 10603295113041
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 229428040
• Device Lot Number: AF1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 09/28/2018
• Supplement Dates FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2006
• 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