MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 15; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92505
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Synovitis (2094); Osteolysis (2377); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/30/2020
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
22 mar 2021.Medical record reviewed.Medical records received were reviewed to identify patient harms/product issues.On (b)(6) 2020, the patient underwent a right hip revision to address osteolysis, elevated metal levels (values not given), early pseudotumor, and limb asymmetry.The surgeon noted synovitis and reactive change in the soft tissue, as well as gray discoloration consistent with metal debris.The trunnion was cleaned with a scratch pad to clear all corrosion.Massive osteolysis was noted around the femur, however, the femur was very well intact and retained along with the cup.The head and liner were revised.There were no indicated intra-operative complications.Task created to update pc.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Examination of the provided x-ray images finds nothing indicative of a product problem.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: as no other reports of any kind were identified over the past five year it is reasonable there was no error in the manufacturing or material of this product/lot combination that would be a contributing factor in the reported allegations.A manufacturing records evaluation (mre) was not performed.Corrected: g1.

• Brand Name: CORAIL AMT COLLAR SIZE 15
• 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: 11631645
• Report Number: 1818910-2021-07373
• Device Sequence Number: 4215984
• Product Code: LZO
• UDI-Device Identifier: 10603295168713
• UDI-Public: 10603295168713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3L92505
• Device Catalogue Number: 3L92505
• Device Lot Number: 2834256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84