MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92511

Device Problem Degraded (1153)

Patient Problems Atrial Fibrillation (1729); Edema (1820); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient had hip pain, elevated cobalt chrome levels and metallosis.Patient alleges atrial fibrillation, hypothyroidism, sleep apnea, edema, insomnia, and pain after review of the medical records, the patient was revised to address painful left total hip replacement secondary to metallosis.Revision operative note reported that the trunnion demonstrated evidence of metallosis with dark staining.

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 Description

There was clear fluid in subfascial plane.Trunnion demonstrated evidence of metallosis with dark staining.

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.

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.

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.

Event Description

Non metal-on-metal medical records: page 9 pfs : pfs alleges initially severe hip and back pain, as well as metallosis and elevated cobalt and chromium ions levels.Pfs alleges that pain is on-going currently page 15 : implant logs stickers for products implanted during revision (b)(6)2019 page 55 : patients metal-on-metal hip revised on (b)(6)2019 to address pain and suspected (confirmed intraoperatively) metallosis, with liner and head exchange to a ceramic-on-polyethylene construct.Reactive and granulomatous tissues were excised and sent for pathology.Metallosis identified between metal head and stem trunnion.Cup and stem were well-fixed and not revised.See additional medical history on page 49 chromium 3.8 mcg/l on (b)(6)2019 cobalt 9.9 mcg/l on (b)(6) 2019 the medical records provide no recent updates to since the revision surgery on (b)(6) 2019.There is no new information apart from the pfs reported allegation of on-going pain.

• Brand Name: CORAIL2 STD SIZE 11
• Type of Device: 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
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopedics drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9898777
• MDR Text Key: 186700858
• Report Number: 1818910-2020-09601
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168775
• UDI-Public: 10603295168775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 3L92511
• Device Catalogue Number: 3L92511
• Device Lot Number: 5025160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 06/15/2021; 03/30/2022; 04/08/2022; 09/28/2022
• Supplement Dates FDA Received: 06/15/2021; 04/03/2022; 04/11/2022; 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASPHERE M SPEC 12/14 36 -2; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 81 KG