MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 LAT COXA VARA SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L93711

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

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

Surgeon broached an 11, then when he implanted the 11 stem it sat up significantly, the stem was removed and another 11 was opened and it sat appropriately.Surgeon believes there was an issue with the stem and would like it analyzed.Case was delayed 10 min as the stem was removed and a new stem was opened and implanted.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 11
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12481060
• MDR Text Key: 271685188
• Report Number: 1818910-2021-20256
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295168881
• UDI-Public: 10603295168881
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L93711
• Device Catalogue Number: 3L93711
• Device Lot Number: 9708885
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention