MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93713
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	08/13/2020
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
Revision of patients hip replacement after it had been implanted for 3 years.The ceramic of the liner was extremely worn and the neck had completely snapped off.The surgeon has asked if we can investigate to ensure that it was not a problem with the implant that caused this prosthetic failure.
Event or Problem Description
Affected side: left 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 device history record (dhr) review was not possible because the required lot code(s) 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.Corrective action was not indicated.The complaint was received into the company with the following comment: we revised this patients hip replacement on 14/8 after it had been implanted for 3 years.The ceramic of the liner was extremely worn and the neck had completely snapped off.The surgeon has asked if we can investigate to ensure that it was not a problem with the implant that caused this prosthetic failure.The case was at aintree hospital with the surgeon.The hospital are processing the implant to ensure it is clean and then are able to send it back to us, would you be able to let me know the process for completing this? 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 code(s) was not provided.Investigational inputs were requested as indicated per internal procedures for this failure mode, however no information was provided to depuy without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative:.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 13
• 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: 10482533
• Report Number: 1818910-2020-19253
• Device Sequence Number: 1246043
• Product Code: KWA
• UDI-Device Identifier: 10603295168904
• UDI-Public: 10603295168904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3L93713
• Device Catalogue Number: 3L93713
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: DELTA CER HEAD 12/14 36MM +5; EA DELTA CER INSERT 36IDX54OD; PINNACLE SECTOR II CUP 54 MM; DELTA CER HEAD 12/14 36MM +5; EA DELTA CER INSERT 36IDX54OD; PINNACLE SECTOR II CUP 54 MM
• Outcome Attributed to Adverse Event: Required Intervention