MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	01/08/2021
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
Clinical adverse event received for trochanteric bursitis.Event is not serious and is considered mild.Event is definitely not related device and possibly related to procedure.Date of implant: (b)(6) 2019, date of event: (b)(6) 2021, (left hip).
Event or Problem Description
Clinic note dated (b)(6) 2021: patient reports pain with compression in the left hip secondary to trochanteric bursitis.Patient denies any pain with walking or any issues with mobility, only reports pain when lying on the operative hip.Physical exam confirms pain on palpation of the hip with excellent mobility and rom.Radiology identifies a stable, well-fixed left hip.Surgeon notes the patient had a previous steroid injection in (b)(6) of 2020, to treat the same issue.The surgeon treated the pain and bursitis with a second steroid injection.There were no complications.
Additional 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.H10 additional narrative: added: b5, b7 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d3 and h6 (patient).From surgical intervention to serious injury.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A review of provided x-ray images finds nothing indicative of a product problem and do not aid in determining a root cause for the reported problems.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 LAT COXA VARA SIZE 12
• 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: 11195898
• Report Number: 1818910-2021-01474
• Device Sequence Number: 11867812
• Product Code: KWA
• UDI-Device Identifier: 10603295168898
• UDI-Public: 10603295168898
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K070554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 01/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3L93712
• Device Catalogue Number: 3L93712
• Device Lot Number: 5317589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 01/25/2021; 02/25/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 02/03/2021; 02/25/2021
• 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 32IDX50OD.; ARTICUL/EZE BALL 32 +5 BR.; CORAIL2 LAT COXA VARA SIZE 12.; PINN CAN BONE SCREW 6.5MMX15MM.; PINN CAN BONE SCREW 6.5MMX20MM.; PINNACLE SECTOR II CUP 50MM.; ALTRX NEUT 32IDX50OD; ARTICUL/EZE BALL 32 +5 BR; CORAIL2 LAT COXA VARA SIZE 12; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 57