MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL AMT SZ10 125 STD N COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number L981210

Device Problems Degraded (1153); Loss of Osseointegration (2408)

Patient Problems Ossification (1428); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 03/15/2021

Event Type  Injury  

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 Description

It was reported that the patient had general pain and thigh pain - mom / corail hip - metal insert exchanged for a poly insert - stem revised to a biomet revision stem - corrosion on taper of corail stem - some osteolysis behind the retained cup was filled with bone graft.No surgical delay.Doi: 2011, dor: (b)(6) 2021, right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.

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.H10 additional narrative: added: b5, d6a, g2 and h6 (clinical codes).H6 clinical symptoms code: metal related pathology (e1618) used to capture blood heavy metal increased and metal poisoning; unspecified tissue injury (e2015) to capture bone injury and soft tissue injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e1, e2, e3.E3 initial reporter occupation: lawyer.

Event Description

Litigation records received.Patient was revised was due to removal of large amount of brown intra articular fluid, excision of metallosis tissue around the liner and neck, heavy metal poisoning from toxic heavy metals, elevated levels of cobalt and chromium, metal wear, tissue and bone destruction.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update 8-feb-2023.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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

After a review of medical records patient was revised due to periprosthetic osteolysis of the internal joint.The femoral component was visibly loose proximally but could not extract easily in the patient x-rays did show persistent bony ingrowth distally.

Event Description

Medical record received: the patient experienced pain with ambulation, x-rays revealed findings of osteolysis and the patient had elevated metal ions and suffered severe obesity.Revision notes stated that a small amount of fluid was encountered.The head was removed.Corrosion at the trunnion was identified.The femoral component was visibly loose proximally but x-rays show some persistent bony ingrowth distally preoperative x-rays revealed a central osteolytic lesion and removed the metal articulating surface and the removed the central apical hole screw and identify the osteolytic cyst in the retro acetabular region.The patient was revised to address osteolysis lesion of the pelvis, hip pain, and elevated metal ions.Prolonged surgery due to severe obesity with a bmi of 38.05.Bone scan shows increased uptake around the right hip femoral component consistent with loosening.The operative note reported corrosion around the trunnion and the femoral component was loose.A clinical visit on mar 13, 2021, reported patient had osteolysis on the femoral component, hip pain, ambulatory function, joint pain, and limited activities of daily living on the right hip.

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.All available photo x-rays evidence was reviewed and does not shows signs of implant corrosion, loosening or any indicative related to a device nonconformance.Based on the information provided as evidence, a defect or malfunction cannot be observed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 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).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).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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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).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 SZ10 125 STD N COL
• Type of Device: CORAIL LINE EXTENSION IMPLANTS : 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 IN 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11575407
• MDR Text Key: 242473909
• Report Number: 1818910-2021-06248
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295452539
• UDI-Public: 10603295452539
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L981210
• Device Catalogue Number: L981210
• Device Lot Number: 5027229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (40 +1.5 METAL HEAD); (56 X 40 MOM LINER); (CORAIL STEM 12 KS); 12/14 ARTICUL 40MM M SPEC+1.5; 12/14 ARTICUL 40MM M SPEC+1.5; APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 11; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE SECTOR II CUP 56MM; PINNACLE SECTOR II CUP 56MM; UNKNOWN HIP ACETABULAR CUP; (40 +1.5 METAL HEAD); (56 X 40 MOM LINER); (CORAIL STEM 12 KS); UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 107 KG