MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 NON COL HO SIZE 10; HIP FEMORAL STEM

Model Number	L20310
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2021
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 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.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > 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 = > 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
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12460609
• Report Number: 1818910-2021-19946
• Device Sequence Number: 1294988
• Product Code: LZO
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/21/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1