MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Cellulitis (1768); Erythema (1840); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Scar Tissue (2060); Synovitis (2094); Dizziness (2194); Distress (2329); Discomfort (2330); Unspecified Mental, Emotional or Behavioural Problem (4430); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Pinnacle mom litigation record received.Patient alleges heavy metal poisoning from the toxic heavy metals, pain, suffered additional scar tissue formation, suffered injury to his muscle and tissue, and now has a hip replacement with decreased longevity.As a direct and proximate result of the defective pinnacle hip replacement, plaintiff suffered injuries, including but not limited to tissue destruction, pseudotumor, black synovitis, metal wear, metal poisoning, loss of enjoyment of life, emotional distress, and limitation of daily activities.Doi: (b)(6) 2006, dor: (b)(6) 2021, (unk hip).

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: a manufacturing record evaluation (mre), 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 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

After review of medical records, the patient was revised on (b)(6) 2021 due to failed right total hip replacement with pseudotumor and adverse tissue destruction to rule out periprosthetic infection.Operative notes reported a significant metallosis and adverse tissue local tissue reaction.The trunnion was ok but there was some corrosion.Affected side: 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.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).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 : a manufacturing record evaluation (mre), 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.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.Swelling/ edema (e2338) is being utilized to capture swelling & edema.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 & 24 aug 2023 received.After review of medical records patient was revised due to failed right total hip replacement, metal on metal total hip with pseudotumor and adverse local tissue destruction, rule out periprosthetic infection.Operative notes indicated a large pseudotumor with black synovitis throughout the hip, significant metallosis and adverse local tissue reaction.The trunnion appeared ok without any damage to the trunnion, but did have some corrosion.On (b)(6) 2019 he underwent a left total hip arthroplasty with the used of competitor implants.Medical records received on sep 21, 2023.In addition to what was previously reported in the medical records received.After review of the medical records the patient was revised to address failed right tha, mom with pseudotumor, adverse local tissue reaction, elevated metal ions, skin rash, hip pain and periprosthetic infection.Operative note reported 20 cc of muddy fluid, brown metallosis type fluid.There was a large pseudotumor with black synovitis and adverse local tissue reaction.The trunnion appeared alright without damage but did have some corrosion.All scar and devitalized was debrided.Removed metal debris and pseudotumor.Pathology reported negative acute inflammation.Patient had pain, significant metal destruction and pseudotumor.This case required increase service intensity and procedural time, increased technical difficuty and physical and mental effort.Clinical visit (b)(6) 2012 synovitis, grade 4 chondrosis, subchondral sclerosis and large marginal osteophytes, multifocal grade 3/4 chondromalacia, diffuse macerated degenerative type medial meniscus tear.Complex joint effusion.Clinical visit on 7/31/2019 pain in the left hip, sepsis, infection, superficial incisional surgical site, numbness, walking difficulty, swelling, rash, weakness, dizziness, lightheaded, distended, tenderness present, erythema and reduce rom and cellulitis.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14111731
• MDR Text Key: 289264517
• Report Number: 1818910-2022-06765
• Device Sequence Number: 1
• Product Code: JDI
• 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: 04/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 04/18/2022; 03/01/2023; 05/20/2023; 06/02/2023; 10/31/2023
• Supplement Dates FDA Received: 04/19/2022; 03/08/2023; 05/31/2023; 06/05/2023; 11/13/2023
• 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: UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White