MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92498
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Inadequate Osseointegration (2646)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
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
Subject id: 017-03844.Study: dots.Clinical notification received for revision of left total hip to address adverse local tissue reaction date of implantation: (b)(6) 2013.Date of revision: (b)(6) 2021.(left hip).On (b)(6) 2021, the patient underwent a left hip revision to address femoral stem loosening at the bone to implant interface.The surgeon noted the removal of fibrous tissue.The stem, head, and liner were revised.The cup and screw were retained.The patient was revised with depuy products.There were no indicated intra-operative complications.
Additional 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: CORAIL AMT COLLAR SIZE 8
• Common Device Name: 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: 11723927
• Report Number: 1818910-2021-08655
• Device Sequence Number: 3946613
• Product Code: KWA
• UDI-Device Identifier: 10603295168645
• UDI-Public: 10603295168645
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: 3L92498
• Device Catalogue Number: 3L92498
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 28IDX50OD; DELTA CER HEAD 12/14 28MM +1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 50MM; ALTRX NEUT 28IDX50OD; DELTA CER HEAD 12/14 28MM +1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 67