MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 06/13/2019

Event Type  Injury  

Event Description

Revision and irrigation & debridement completed for possible infection.Original implant date unknown.Doi: unknown.Dor: (b)(6) 2019 left hip.

Manufacturer Narrative

(b)(4) - jul 06 2022.Update ad 5 jul 2022: (b)(4) has been reopened due to the receipt of mom pinnacle litigation record.Patient alleges elevated metal ion, suffered injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.As a direct and proximate result, patient suffered pain, injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, economic loss, emotional trauma and distress, mental anguish, immobility, permanent instability and loss of balance, and physical disability.Added stem to this complaint due to elevated metal ion allegation.Added lawyer and law firm.Added doi.Doi: (b)(6) 2008 - dor: (b)(6) 2019 (left hip).Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

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: 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.Swelling/ edema (e2338) is used to capture swelling and edema.Metal related pathology (e1618) is used to capture metal poisoning and blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review, the patient had a hematoma on left greater trochanter.

Manufacturer Narrative

Product complaint # (b)(6) 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

Medical records were received and stated the following: on (b)(6)2019 patient presented to the emergency department due to severe left hip pain.The patient states the pain is 10 out of 10 shooting aching pain that started last night with significant bruising patient denies falling and injury.She states she had left total hip replacement with dr.Lawrence 6 months ago and she had a similar episode of pain, bruising, and swelling 2 months ago when she was diagnosed with a hematoma.The patient states pain gets worse with walking and she has radiation of pain down to her left calf.She is unable to ambulate due to pain.However, there was no scheduled revision.Doi: (b)(6)2008.Dor: (b)(6)2019 left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence found nothing indicative of a device nonconformance that could have contributed to the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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

Medical records received: on (b)(6) 2008, the patient had a left total hip anterior approach to address degenerative joint disease.Depuy pinnacle cup, metal insert, femoral head, corail, and apex hole eliminator.On (b)(6) 2019 the patient had an mri, it was reported to show left hip had an increased signal most prominent in the region of the greater trochanter of the femur and also in the acetabular region.There was no fracture of bone noted.Alval was present.On (b)(6) 2019 patient had a left total hip revision, head/liner exchange for mom pseudotumor, metallosis.Prior to surgery, it was noted that the patient had limited activity, limited mobility, and pain.Metal on metal components were revised to poly to femoral head.Intraoperative findings included pseudcyst, metal staining on the back of metal liner, depuy poly liner, depuy metal head were implanted during this procedure.The legal document alleges elevated metal levels, pain, discomfort, difficulties standing, sitting, walking, climbing stairs, and performing normal daily living activities, inability to sleep and diminished quality of life.

Manufacturer Narrative

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, b6, b7 and h6 (clinical code).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.H10 additional narrative: 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.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records ad 17 jan 2024 received: page 4: on 25 jul 2023, patient was seen in the clinical setting for reported patient fall resulting in patient "hurting her knee" with no additional details provided.There is no evidence of musculoskeletal or skin issues per the physical exam.The patient's pain scale rating is reported to be 8 (the actual details of the scale are not provided).Page 41: on 02 sep 2022, patient was seen in clinic for migraine headache (no indication it was at all related to patient's extremity joints, but was stated to be probably sinusitis related.Patient also complained of left knee pain, without further details.Patient indicated also that she was waiting for a total left shoulder repair, postponed due to covid-19.Page 48: on 09 nov 2020: patient was "seen" in clinic via telehealth, and discussed that she had seen an orthopedic surgeon for her back, for which she was diagnosed as having a large amount of arthritis and deterioration.Her cardiac status was poor though, so surgery at that time was not an option--therapy was the treatment she was going to proceed with in lieu of surgery.Page 401: same as report from page 4.On 5 jul 2023, patient was seen in the clinical setting for reported patient fall resulting in patient "hurting her knee" with no additional details provided.

• Brand Name: CORAIL2 STD SIZE 10
• 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 IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15076131
• MDR Text Key: 296320362
• Report Number: 1818910-2022-13675
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295168768
• UDI-Public: 10603295168768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/21/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 3L92510
• Device Catalogue Number: 3L92510
• Device Lot Number: 2598828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 03/01/2023; 03/20/2023; 03/28/2023; 04/11/2023; 05/22/2023; 10/17/2023; 01/17/2024
• Supplement Dates FDA Received: 03/15/2023; 03/20/2023; 04/04/2023; 04/12/2023; 06/13/2023; 10/23/2023; 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2020
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM -2; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 90 KG