MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL AMT COLLAR SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92502
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646); Limb Fracture (4518)
Date of Event	04/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had multiple surgeries.On (b)(6) 2021 hemi arthroplasty was done and stem remains from this procedure.On (b)(6) 2021 hip dislocated and converted to constrained total hip by surgeon.On (b)(6) 2021 cup was revised and dual mobility was placed by surgeon.Der was filed, cup and screw that listed on the der, placed at this time.On (b)(6) 2022 it was converted to dm to constrained due to dislocation.Der was submitted, head and liner placed at this time.Patient presents in er with a periprosthetic fracture of right hip with appearance of possible infection superior to acetabular component.All components removed and prostalac placed uneventfully.There was loosening of femoral component post fracture at bone to implant interface.Doi: (b)(6) 2021.Dor: (b)(6) 2023.Affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Additional information received indicated that there were no instrumentations that broke.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CORAIL AMT COLLAR SIZE 12
• 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; st. priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16859965
• Report Number: 1818910-2023-09464
• Device Sequence Number: 5830712
• Product Code: LZO
• UDI-Device Identifier: 10603295168683
• UDI-Public: 10603295168683
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2023

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: 3L92502
• Device Catalogue Number: 3L92502
• Device Lot Number: 9679476
• 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: 04/22/2023
• Supplement Date Received by Manufacturer: 05/03/2023; 05/19/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/11/2023; 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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: ARTICULEZE M HEAD 36MM +15.5.; PIN LNR CONS NEUT +4 36IDX58OD.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN SECTOR W/GRIPTION 58MM.; UNKNOWN BONE CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male