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

Model Number	3L93714
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1818910-2021-00973
• Device Sequence Number: 19705246
• Product Code: LZO
• UDI-Device Identifier: 10603295168911
• UDI-Public: 10603295168911
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 3L93714
• Device Catalogue Number: 3L93714
• Device Lot Number: 5258397
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/21/2021; 02/11/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/02/2021; 02/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR