MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL2 STD SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92511

Device Problem Degraded (1153)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Injury (2348); Osteolysis (2377); No Code Available (3191)

Event Date 09/19/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation papers allege severe injury, implant failure, pain and discomfort.Plaintiff¿s preliminary disclosure form was received, which identified dob information.Part & lot were identified through patient's sticker sheet.The complaint and associated mdrs were updated.After review of medical records patient was revised to address failed left hip replacement secondary to metal adverse local tissue reaction and proximal femoral osteolysis.Revision notes reported that the acetaular and femoral component were well fixed despite the proximal femoral osteolysis.There was extensive corrosion at the taper junction between the large femoral head and the stem.There was a moderate amount of joint fluid and was some was sent for cell count and culture.The femoral head was removed with a punch and mallet and corrosion was noted as described above.

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.

• Brand Name: CORAIL2 STD SIZE 11
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10696939
• MDR Text Key: 211887874
• Report Number: 1818910-2020-22708
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168775
• UDI-Public: 10603295168775
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L92511
• Device Catalogue Number: 3L92511
• Device Lot Number: 2367075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR