MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 10; HIP FEMORAL STEM

Model Number L20310

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.The device catalog number is unknown; therefore, udi is unavailable.(b)(4).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.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.

Event Description

Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning from toxic heavy metals resulting to injuries in the muscle, tissue, scar tissue formation, metallosis, metal wear, limited adl, pain, emotional trauma and distress.Doi: unknown; dor: (b)(6) 2022; hip unknown.

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.

Event Description

Medical records received.Revision notes stated that significant synovial fluid was noted as well as extensive blackened synovial tissue.

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.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.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: as a result of the defective hip device, it developed elevated chromium cobalt levels, metallosis, instability, tissue and bone damage, suffered severe pain and discomfort, difficulties standing, sitting, walking, climbing stairs, and performing normal daily living activities, inability to sleep due to pain and discomfort.Doi: (b)(6) 2007.Dor:(b)(6), 2022.Affected side: left 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.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.Corrected: h6 (clinical code).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available x-rays were reviewed found nothing indicative of a device nonconformance or a relation with the reported adverse 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.

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.

Event Description

After review of medical records patient was revised due to other mechanical complications of internal left prosthesis.Operative notes indicated significant synovial fluid was noted as well as extensive blackened synovial tissue consistent with advanced metallosis.The acetabular and femoral components were well-fixed and well aligned.On (b)(6) 2019 she underwent a right total hip arthroplasty due to osteoarthritis with a competitor implant being used.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.All available x-rays were reviewed found nothing indicative of a device nonconformance or a relation with the reported adverse event.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 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: CORAIL2 NON COL HO SIZE 10
• Type of Device: 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15916349
• MDR Text Key: 304815163
• Report Number: 1818910-2022-24333
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/05/2022

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 Expiration Date: 03/24/2012
• Device Model Number: L20310
• Device Catalogue Number: L20310
• Device Lot Number: 2327921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 03/01/2023; 03/14/2023; 05/20/2023; 06/26/2023; 08/21/2023; 10/13/2023; 11/10/2023
• Supplement Dates FDA Received: 03/13/2023; 03/15/2023; 06/07/2023; 06/27/2023; 09/15/2023; 10/23/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2007
• 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 +5.; PINNACLE 100 ACET CUP 50MM.; PINNACLE MTL INS NEUT36IDX50OD.; UNK HIP ACETABULAR CUP PINNACLE.; UNK HIP ACETABULAR LINER METAL PINNACLE.; UNK HIP FEMORAL HEAD METAL.
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 65 KG