MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Unspecified Infection (1930); Loss of Range of Motion (2032); No Code Available (3191)
Date of Event	05/31/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4) used to capture the surgical intervention.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
Ppf and medical records.Ppf alleged infection after the first revision.After review of the medical records, the patient was revised to address infection.Doi: (b)(6) 2010.Dor: (b)(6) 2012 (left hip) second revision.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 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.
Event or Problem Description
Pfs alleges limited range of motion and weakness.Ppf alleges infection.After review of medical records, it was indicated that the patient was revised for failed left tha secondary to infection and a stage 1 of 2 revision was performed.Operative notes and date of surgery were not provided.Doi: (b)(6) 2008 (cup and stem), doi: (b)(6) 2010 (head and liner), dor: unknown (1st stage revision), left hip.

• Brand Name: CORAIL2 STD SIZE 15
• 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: 9139711
• Report Number: 1818910-2019-106953
• Device Sequence Number: 1825388
• Product Code: KWA
• UDI-Device Identifier: 10603295168812
• UDI-Public: 10603295168812
• 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
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2019

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: 3L92515
• Device Catalogue Number: 3L92515
• Device Lot Number: 2437450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 09/06/2021
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/10/2019; 09/17/2021
• 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; PINN MAR NEUT 36IDX56OD; PINNACLE SECTOR II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR