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	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	10/23/2020
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 the patient recently had surgery and developed an infection shortly after.She came back in for an i&d, potential poly/head swap.Upon opening the joint and trying to remove the head the stem became loose at bone to implant interface.At this point the surgeon decided to remove all implants and put a temporary spacer until the infection clears.Doi: (b)(6) 2020 - dor: (b)(6) 2020 (left hip).
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 sterilization that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 10801912
• Report Number: 1818910-2020-24104
• Device Sequence Number: 17058125
• Product Code: KWA
• UDI-Device Identifier: 10603295168713
• UDI-Public: 10603295168713
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 3L92505
• Device Catalogue Number: 3L92505
• Device Lot Number: 5365363
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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: ALTRX +4 10D 32IDX48OD; CORAIL AMT COLLAR SIZE 15; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 48MM; PINNACLE BONE SCREW 35 MM; ALTRX +4 10D 32IDX48OD; CORAIL AMT COLLAR SIZE 15; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 48MM; PINNACLE BONE SCREW 35 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR