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

Model Number L20311

Device Problem Migration (4003)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 12/02/2020

Event Type  Injury  

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

This is a revision of the corail and pinnacle hip.This was revised due to the corail stem's subsidence, and the ceramic lined was chipping off.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that the patient was experiencing pain that led to the revision surgery.Affected side if left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A photographic image of the explanted femoral stem was provided.It was not possible to confirm the reported subsidence or determine a root cause using a photographic image.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 : the product investigation found no evidence suspecting an error in the manufacturing or material 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 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: 11021039
• MDR Text Key: 221811328
• Report Number: 1818910-2020-27091
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295258025
• UDI-Public: 10603295258025
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Device Lot Number: 5034602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CERAMAX CERAMIC INSERT 36 X 54; DELTA CER HEAD 12/14 36MM +5; PINNACLE 100 ACET CUP 54MM; CERAMAX CERAMIC INSERT 36 X 54; DELTA CER HEAD 12/14 36MM +5; PINNACLE 100 ACET CUP 54MM
• Patient Outcome(s): Required Intervention