MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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 08/21/2021

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 the kho size 10 corail stem was found to have a package expiration date of 6/30/2021 after patient was closed and in recovery.Doe: (b)(6) 2021 affected side: right hip.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> no device associated with this report was received for examination.No distribution error identified.Root cause: user error for not having verified sterile expiry date before having used the device.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.Device history lot
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> the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL2 NON COL HO SIZE 10
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12460609
• MDR Text Key: 271049181
• Report Number: 1818910-2021-19946
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• 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
• Report Date: 08/21/2021

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 Expiration Date: 06/30/2021
• Device Model Number: L20310
• Device Catalogue Number: L20310
• Device Lot Number: 5273896
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1