MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92503

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Dislocation (2374)

Event Date 04/12/2021

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

Patient was revised to treat a dislocation of the head and liner that the surgeon attributed to a loosened sup and screws and an undersized femoral stem.The patient received a multihole dual mobility cup.The surgeon notes there was no defect of the head and liner.Doi: (b)(6) 2021; dor: (b)(6) 2021; hip unknown.

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, 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 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: CORAIL AMT COLLAR SIZE 13
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : 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: 11753273
• MDR Text Key: 248205840
• Report Number: 1818910-2021-09269
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168690
• UDI-Public: 10603295168690
• Combination Product (y/n): N
• PMA/PMN Number: K070554
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L92503
• Device Catalogue Number: 3L92503
• Device Lot Number: 9641121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+5; ALTRX +4 NEUT 40IDX56OD; CORAIL AMT COLLAR SIZE 13; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; UNK HIP ACETABULAR CUP PINNACLE; 12/14 ARTICUL 40MM M SPEC+5; ALTRX +4 NEUT 40IDX56OD; CORAIL AMT COLLAR SIZE 13; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; UNK HIP ACETABULAR CUP PINNACLE
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR