MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 LAT COXA VARA SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	12/22/2021
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.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent the tha surgery for oa with the stem in question.The surgery was completed successfully without any surgical delay.After the surgery, at the medical examination in may, the patient said that the affected area felt strange, but there was no abnormality on the images.The patient was revised on (b)(6) 2021.No further information available.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 15
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13235563
• Report Number: 1818910-2022-00653
• Device Sequence Number: 4547228
• Product Code: LZO
• UDI-Device Identifier: 10603295168928
• UDI-Public: 10603295168928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: 3L93715
• Device Catalogue Number: 3L93715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male