MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 12; HIP FEMORAL STEM

Catalog Number L20314

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

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

Description of the event according to the nurse: "on tuesday i did a surgery in the (b)(6) (hospital) and used the corail standard size 12.It all went well.But today ((b)(6)) i have received a replacement with sonia and i realized that the sticker (label) came wrong in the implant, since it said stem corail ho 14." email shows picture of the label: corail hip system, kho size 14.Code: l20314; lot: 5274570.

Manufacturer Narrative

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: the complaint reports an incorrect inside label, of a corail sz 14 stem ( code: (b)(4) , lot: (b)(4)) inside a corail sz 12 stem packaging.The reporter confirmed that the external label of the size 12 stem as well as actual implant were correct.The issue reported was therefore only in relation to the internal labels.The product code of the size 12 stem was received (b)(4) / lot.(b)(4).The analysis performed by the supplier revealed that batch (b)(4) was shipped to depuy a year before batch (b)(4).A stop shipment was issued for this issue (b)(4).A product from batch (b)(4) was inspected, the product etching, external and internal labels were conform.No product from batch (b)(4) was available for inspection.No other similar complaints have been received for these affected batches.Based on the information received and the investigation performed, no manufacturing issue was detected.The root cause of the issue could not be determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 STD SIZE 12
• Type of Device: 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 IRELAND 9616671; loughbeg ringaskiddy co.; b.p. 256; cork 69801 ; EI 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7638062
• MDR Text Key: 112337487
• Report Number: 1818910-2018-63214
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295258056
• UDI-Public: 10603295258056
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: L20314
• Device Lot Number: 5255122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR