MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 LAT COXA VARA SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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
The patient was revised due to pain.Doi: unknown - dor: (b)(6) 2021 (right hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 12
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12211221
• Report Number: 1818910-2021-15739
• Device Sequence Number: 14620686
• Product Code: KWA
• UDI-Device Identifier: 10603295168898
• UDI-Public: 10603295168898
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K070554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 3L93712
• Device Catalogue Number: 3L93712
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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: CORAIL2 LAT COXA VARA SIZE 12.; UNK HIP FEMORAL HEAD CERAMIC.; CORAIL2 LAT COXA VARA SIZE 12; UNK HIP FEMORAL HEAD CERAMIC
• Outcome Attributed to Adverse Event: Required Intervention