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

Catalog Number	3L92515
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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
Revision of right hip replacement due to loosening, bearing surface was ceramic head on metal liner.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary = > with the information available it was deemed that it is unlikely that a potential product issue was present and that no corrective action is required.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The products shall be retained in a secure location for future reference unless specifically requested to be returned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

• 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; depuy france sas - 3003895575; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 8551881
• Report Number: 1818910-2019-91662
• Device Sequence Number: 1744289
• Product Code: KWA
• UDI-Device Identifier: 10603295168812
• UDI-Public: 10603295168812
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3L92515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/02/2019; 07/01/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/28/2019; 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR