MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 10; HIP FEMORAL STEM

Model Number L20310

Device Problem Expiration Date Error (2528)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

The expired product was used during the hip surgery.The expiry date of product was 2/28/2022.No other information about the patient condition is available at this moment.Product is implanted in patient body.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device product code l20310, lot number 5290633, and no non-conformances / manufacturing irregularities were identified.

Event Description

Additional information received.A.Was there a surgical delay? what was the duration of the delay? -no delay.B.Affected side: -left.C.Was/were there any adverse consequence/s that affected the patient because of the reported event? -no consequences.

• Brand Name: CORAIL2 NON COL HO SIZE 10
• 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 FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14548650
• MDR Text Key: 293004638
• Report Number: 1818910-2022-09810
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K190344
• 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
• Report Date: 05/31/2022

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: L20310
• Device Catalogue Number: L20310
• Device Lot Number: 5290633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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