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 Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Pcf and medical records received.After review of medical records, no revision notes reported.Patient alleges chronic pain, stiffness, walking difficulty, swelling, difficulty in wearing shoes and socks, difficulty with stairs, painful antalgic gait, limp, arthralgias, joint swelling, and myalgias.Physical exam stated decreased strength, tenderness, bony tenderness, swelling, and crepitus.Laboratory results stated elevated metal ions.Doi: (b)(6) 2008.Dor: none reported; (left hip).Patient is bilateral.See (b)(4) for the right hip.
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, 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.
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, 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.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10055968
• Report Number: 1818910-2020-12086
• Device Sequence Number: 3293479
• Product Code: KWA
• UDI-Device Identifier: 10603295168898
• UDI-Public: 10603295168898
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/29/2020

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: 2535539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 04/21/2021; 04/21/2021; 04/21/2022
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/26/2020; 04/29/2021; 04/25/2022; 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM -2; CORAIL2 LAT COXA VARA SIZE 12; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM
• Patient Sex: Male