MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 14; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L93714

Device Problem Expiration Date Error (2528)

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

Event Date 01/04/2021

Event Type  malfunction  

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.

Event Description

It was reported that during surgery it was discovered that the size of the stem requested by the surgeon and appropriated to the broach used was expired.The corail stem was then implanted by the surgeon into the patient.It was the only sized in the hospital.Doi: (b)(6) 2020.Dor: none reported.Left hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

A.Was there any adverse consequences that affected the patient because of the reported event? b.Was there a surgical delay because of this event? if yes, what is the duration of the delay? c.Was there any issues with the clarity of the labeling that led to the expired product being used? answer: there wasn't any adverse reactions to the patient, and the time of the surgery wasn't extended due to the fact that the surgeon didn't want to wait for a non expired implant to be brought to the hospital.The fact that the expired implant was missed by our local office, and the rep covering the case was a rare oversight, and has since been discussed, we have had several trainings, and also been required by our local distributor to recheck all current inventory in our warehouse and hospitals where there are implants.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device or packaging materials associated with this report was received for examination.No distribution error identified.All devices from this product/lot combination were distributed well prior expiry.The root cause is attributed to use error.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 14
• 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
• MDR Report Key: 11164134
• MDR Text Key: 226609944
• Report Number: 1818910-2021-00973
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295168911
• UDI-Public: 10603295168911
• Combination Product (y/n): N
• PMA/PMN Number: K190344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

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 Model Number: 3L93714
• Device Catalogue Number: 3L93714
• Device Lot Number: 5258397
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/21/2021; 02/11/2021
• Supplement Dates FDA Received: 02/02/2021; 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR