MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 9; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93709
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	05/04/2021
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
Right hip stem collapsed into varus and needed to be revised.Original dos (b)(6) 2020.
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.
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 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 g1.
Event or Problem Description
Questions: a.Was there a surgical delay during the revision surgery? if yes, what was the duration of the delay? b.Was the patient experiencing any adverse symptoms that led to the revision surgery? answers for your questions: patient was revised due to painful total hip.There was no surgical delay.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 9
• 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 IN 69801 ; FR 69801
• MDR Report Key: 11825553
• Report Number: 1818910-2021-10291
• Device Sequence Number: 3663560
• Product Code: KWA
• UDI-Device Identifier: 10603295168867
• UDI-Public: 10603295168867
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2021

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: 3L93709
• Device Catalogue Number: 3L93709
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/18/2021; 06/14/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 05/31/2021; 06/15/2021
• 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: ARTICULEZE M HEAD 36MM +1.5.; CORAIL2 LAT COXA VARA SIZE 9.; ARTICULEZE M HEAD 36MM +1.5; CORAIL2 LAT COXA VARA SIZE 9
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 100