MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL CEM STEM STD S8; JRN : HIP FEMORAL STEM

Catalog Number L96408

Device Problems Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 an implantation of a corail stem on (b)(6) 2023.After implantation if became obvious that stems´s expiry date was 30-nov-2022.Patient is fine.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary:the device associated with this report was not returned to depuy synthes for evaluation, nor photographs were provided.However based on the event description, device and other information provided, the reported allegation can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 23-dec-2017 3) any anomalies or deviations identified in dhr: there is one nr-0087507, but it has nothing to do with this complaint/malfunction.4) expiry date: 30-nov-2022.5) ifu reference: ifu-78410386.

• Brand Name: CORAIL CEM STEM STD S8
• Type of Device: JRN : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17330895
• MDR Text Key: 319206958
• Report Number: 1818910-2023-14420
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2023

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 Expiration Date: 11/30/2022
• Device Catalogue Number: L96408
• Device Lot Number: D17122422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/16/2023
• Supplement Dates Manufacturer Received: 07/27/2023; 02/01/2024
• Supplement Dates FDA Received: 07/28/2023; 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2017
• 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