MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 135D KHO HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number L94006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  Malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Dr (b)(6), (b)(6) hospital (b)(6) 2018. Using the kho neck segment when trialing the stem and head, when surgeon went to change the trial head option the metal o-ring came off. Neck segment could be used but head would not stay on tight and secure. Female patient id: (b)(6).

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.

Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: examination of the device confirmed the failure mode as reported. 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: CORAIL AMT NECK SEG 135D KHO
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; bp 256; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 7453735
• MDR Text Key: 106260217
• Report Number: 1818910-2018-58109
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (Y/N): N
• Reporter Country Code: AS
• PMA/PMN Number: K142004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: HEALTH PROFESSIONAL
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/24/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: L94006
• Device LOT Number: NB103973
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage