MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 11; HIP FEMORAL STEM

Model Number L20311

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

(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

The patient was revised to address loosening of the stem at the bone to implant interface.The stem was also subsided so the surgeon removed head, stem, and metal liner and replaced it with a new poly liner and a competitor revision stem.Couldn¿t locate anything from the previous surgery.Original implant date unknown.Doi: unknown.Dor: (b)(6) 2020; affected side: left hip.

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 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 device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: CORAIL2 NON COL HO SIZE 11
• 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
• MDR Report Key: 11077038
• MDR Text Key: 223760781
• Report Number: 1818910-2020-27648
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295258025
• UDI-Public: 10603295258025
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L20311
• Device Catalogue Number: L20311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 36X54 NEUTRAL METAL LINER; DELTA CER HEAD 12/14 36MM +5; 36X54 NEUTRAL METAL LINER; DELTA CER HEAD 12/14 36MM +5
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR