MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 16; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92516
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Test Result (2695); Not Applicable (3189)
Date of Event	03/22/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.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
Update (b)(6) 2018: asr medical records received.  after review of medical records, the patient was revised due to aseptic loosening of the left hip joint endoprosthesis acetabulum, metallosis, and femur fracture.Revision notes reported the head was broken away, stable stem, and loose acetabulum removed.Lab result shows metal ion levels above 7 ppb.  doi: (b)(6) 2009; dor: (b)(6) 2014; left hip. .
Additional Manufacturer Narrative
(b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.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.

• Brand Name: CORAIL2 STD SIZE 16
• 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: 7591152
• Report Number: 1818910-2018-61892
• Device Sequence Number: 10833919
• Product Code: KWA
• UDI-Device Identifier: 10603295168829
• UDI-Public: 10603295168829
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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 Expiration Date: 04/30/2013
• Device Catalogue Number: 3L92516
• Device Lot Number: 2586816
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/18/2018
• 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: 59 YR