MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 10 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number 3L92500

Device Problem No Apparent Adverse Event (3189)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that the surgeon confirmed the plate (manufactured by zimmer) was broken on (b)(6) 2019 thus, the revision surgery was performed on (b)(6) 2019 by explanting the plate and replacing from the stem (p/n: 3l92500) to the s-rom a stem. Synostosis at the distal end of the stem was severe and could not be removed with a slap hammer, and also it could not be removed with a chisel. The surgeon attempted to remove via eto, it could not be removed. As a result, the condition of at the proximal femoral got worse because there were also screw holes, the surgeon replaced from the stem in question to the s rom a stem. The surgery was completed 60 minutes delay. No further information is available.

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary
==
> no device associated with this report was received for examination. 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL AMT COLLAR SIZE 10
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• 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 INTERNATIONAL LTD. 8010379; st. anthony's rd; bp 256; leeds ; UK
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8497102
• MDR Text Key: 141380478
• Report Number: 1818910-2019-90239
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 3L92500
• Device Lot Number: 5315238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/09/2019 Patient Sequence Number: 1