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

Model Number	3L92509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Test Result (2695)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.Initial reporter occupation: lawyer.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
Asr index procedure.Asr xl.Right hip.Reason for complaint: high blood cobalt and chromium levels.Doi: unknown.Dor: unknown.
Additional Manufacturer Narrative
Product complaint # (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.

• Brand Name: CORAIL2 STD 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 69801 ; FR 69801
• MDR Report Key: 9377697
• Report Number: 1818910-2019-118116
• Device Sequence Number: 3077648
• Product Code: KWA
• UDI-Device Identifier: 10603295168751
• UDI-Public: 10603295168751
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 3L92509
• Device Catalogue Number: 3L92509
• Device Lot Number: 2364521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1749/1816-2011
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention