MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM CORAIL

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

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Fatigue (1849); Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Balance Problems (4401); Limb Fracture (4518); Joint Laxity (4526); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 06/14/2022

Event Type  Injury  

Event Description

Mom pinnacle litigation record received.Patient alleges elevated metal ion, patient alleges 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.Doi: (b)(6) 2009; dor: (b)(6) 2022; (unk hip).

Manufacturer Narrative

Product complaint # (b)(4).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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint #
=
> pc-(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: a2 (age, dob), a3, b5, b6, b7, h6 health effect - clinical code h6: unspecified tissue injury (e2015) is being utilized to capture bone injury & 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: a1, d1, d2a, d3, d4, d6a, d10 (concomitant), g1.

Event Description

After review of the medical records, the patient was revised to address right hip pain, periprosthetic osteolysis, metallosis, greater trochanter fracture, osteolysis in acetabulum and femur, pseudotumors, and neurolysis.Operative note reported trochanter fracture and pseudotumor.There was a very thick gelatinous material.This was dark in appearance and filled the entire hip capsule.Excised pseudotumor and neurolysis due to proximity of sciatic nerve.The socket posterolateral wall was missing.There was osteolysis in the stem.Procedures done were revision of right tha, excision of pseudotumor, neurolysis, capsulorrhaphy, bone grafting cup and femur, and biopsy for muscle tendon and bone deep.Doi: apr 9, 2009; dor: jun 14, 2022; 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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Medical records received.After review of the medical records, there was no new harm or device-related problem provided.Litigation records allege due to defective design and manufacturing processes plaintiff suffered a fractured trochanter, there was hip soreness, and pain, and unable to get out of bed without assistance the day after.The fractured greater trochanter was confirmed in his x-rays.The litigation alleges periprosthetic osteolysis, metallosis, greater trochanter fracture, and osteolysis in the acetabulum and femur.Plaintiff underwent revision with excision of the pseudotumor, sciatic nerve neurolysis, and bone grafts for both the acetabulum and proximal femur.There was severe bone deterioration that was unable to perform bone grafts.Plaintiff developed a large fluid collection around the hip resulting to metallosis, pseudotumor, severe pain, fractured trochanter, and osteolysis.Plaintiff suffered pain, discomfort, walking difficulty, limited adl and emotional distress, and inability to sleep.Plaintiff alleges adverse local tissue reaction and toxic heavy metal however, the lab result reported metal ions are below 7 ppb.

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: a4, a5, a6, b5, b7, h6 health effect - 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).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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Medical records received.After review documented findings were cyst : fluid collection, capsulorrhaphy, bone grafting ( acetabulum & proximal femur ).Patient underwent left knee arthroplasty however utilizing competitors devices.Implants remained unknown as there were no sticker sheets 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, b6, h6 health effect - clinical code.H6: unspecified musculoskeletal problem (e1635) is being utilized to capture bone disorder.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 received.Patient visited the clinic due to stiffness of right hip, difficulty in walking, pain in right hip, unsteadiness on feet, loss of function, swelling, and muscle weakness.Increasing pain from 0/10 to 7/10.Doi: (b)(6) 2009; dor: (b)(6) 2022; 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.Added: b5, b6, b7, h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15084795
• MDR Text Key: 296393129
• Report Number: 1818910-2022-13703
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/22/2022

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 Catalogue Number: UNK HIP FEMORAL STEM CORAIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/25/2022; 03/01/2023; 03/10/2023; 04/14/2023; 05/17/2023; 08/21/2023; 09/22/2023
• Supplement Dates FDA Received: 07/26/2022; 03/09/2023; 03/13/2023; 04/21/2023; 05/17/2023; 09/06/2023; 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SIZE +8.5 METAL HEAD; SIZE 12 CORAIL STANDARD OFFSET; SIZE 36 METAL LINER; SIZE 52 PINNACLE SECTOR GRIPTION ACETABULAR CUP; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White