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

Catalog Number UNK HIP FEMORAL HEAD METAL

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Metal Related Pathology (4530)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.

Event Description

This complaint was created in relation to aei note (b)(4) under pc-(b)(4) stated that pc-(b)(4) medical records ad (b)(6) 2023 (2), pc-(b)(4) medical records ad (b)(6) 2023 (3) were reviewed by clinician.On (b)(6) 2006, the patient had a left total hip arthroplasty to address osteoarthritis.Depuy components were placed during this procedure.On (b)(6) 2010, the patient had a right total hip arthroplasty to address osteoarthritis.Depuy components were implanted at this time.On (b)(6) 2022, the patient had a right revision to address failed right total hip arthroplasty.It was noted the patient had pain, elevated serum levels of cobalt and chromium, and radiographs showed osteolysis.Depuy metal on metal head/liner were revised to a poly on ceramic construct.Depuy components were implanted during this procedure.This complaint was created due to elevated metal ion allegation.Doi: (b)(6) 2006.Dor: unknown.(left 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) will not be performed since mom systems are obsolete.

Event Description

Operative findings: hematoma, fascia/gluteus dehiscence.

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 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 reviewed.(b)(6) 2022, chromium lab:2.5 ug/l and cobalt 8.8 ug/l (page 1288) (left hip is metal on metal) (b)(6) 2022 medical records note the patient started experiencing leaching of metals in her 10+ year old replacement hip joint into her body and causing cognitive and psychological changes" (389) (b)(6) 2022 lab results are noted to be cobalt 5.4 (b)(6) 2022 neurological visit to address elevated blood and serum and cobalt level and potential that it could be causing cognitive symptoms.It was noted that it was unlikely at that the patient¿s level to cause neurological symptoms or contribute to the patient¿s mild cognitive impairment.(b)(6) 2023 cobalt 5.2 and chromium 3.4 (no unit of measurement provided) (b)(6) 2023 follow-up for elevated high levels of cobalt and chromium with cognitive changes.(b)(6) 2023 cobalt 6.3mcg/l chromium 2.6 mcg/l (b)(6) 2023 the patient has bilateral hip pain, worse on the right.The patient has had mental confusion.The patient still has metal on metal left hip and elevated metal ion levels.

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: UNK HIP FEMORAL HEAD METAL
• Type of Device: HIP 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: 16654865
• MDR Text Key: 312412878
• Report Number: 1818910-2023-07021
• 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: 03/31/2023

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 HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 05/03/2023; 08/21/2023; 09/28/2023; 01/17/2024
• Supplement Dates FDA Received: 05/03/2023; 09/18/2023; 10/17/2023; 01/23/2024
• 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: UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP ACETABULAR LINERS.; UNKNOWN HIP FEMORAL HEAD.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 92 KG