MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CORAIL2 NON COL HO SIZE 9; HIP FEMORAL STEM

Catalog Number	L20309
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
Date of Event	06/23/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
Litigation alleges that patient has experienced severe pain.Additionally, it is alleged that toxic amounts of cobalt and chromium are making their way into patient's hip joint and blood stream.Update ad 27 june 2018 receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges loosening of the stem and elevated metal ions.Added stem due to the allegation.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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.Corrective action was not indicated.

• Brand Name: CORAIL2 NON COL HO SIZE 9
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; b.p. 256; warsaw IN 46582 0988
• MDR Report Key: 8226136
• Report Number: 1818910-2019-80132
• Device Sequence Number: 11261806
• Product Code: KWA
• UDI-Device Identifier: 10603295258001
• UDI-Public: 10603295258001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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 Catalogue Number: L20309
• Device Lot Number: 2739064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 66