MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92498
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
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.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent the tha surgery for left hip.After the surgery, signs of stress shielding developed at the bone around the distal stem due to loading.On unknown date, revision surgery was performed.In the revision surgery, the implants used in the first surgery were removed and replaced with other company¿s implants.The revision surgery was completed successfully without any surgical delay.Doi: (b)(6) 2018, dor: unknown, left hip.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot = > a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: CORAIL AMT COLLAR SIZE 8
• 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 IN 69801 ; FR 69801
• MDR Report Key: 12540654
• Report Number: 1818910-2021-21271
• Device Sequence Number: 4231665
• Product Code: KWA
• UDI-Device Identifier: 10603295168645
• UDI-Public: 10603295168645
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2021

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 Expiration Date: 08/01/2022
• Device Model Number: 3L92498
• Device Catalogue Number: 3L92498
• Device Lot Number: 5299906
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 11/03/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/01/2021; 11/04/2021
• 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: CORAIL AMT COLLAR SIZE 8; DELTA CER HEAD 12/14 32MM +1; CORAIL AMT COLLAR SIZE 8; DELTA CER HEAD 12/14 32MM +1
• Outcome Attributed to Adverse Event: Required Intervention