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 Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Catalog the device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer component code: appropriate term/code not available (g07002) used to capture no findings available.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.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

Litigation record received.Litigation reported that on (b)(6) 2008, patient had a left total hip arthroplasty due to degenerative osteoarthritis and a pinnacle metal on metal hip was implanted.Overall the years patient suffered heavy metal poisoning from toxic heavy metals released by the hip and as a result patient injury a required surgery to remove defective hip was placed on (b)(6) 2022, patient undergone surgical removal due to toxic heavy metal poisoning and pseudotumor.Suffered injured includes significant pain, permanent tissue destruction, permanent muscle and bone destruction, metal wear and removal of pseudotumor and metal poisoning.Doi: on (b)(6) 2008; dor: on (b)(6), 2022; 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.Clinical symptoms code: metal related pathology (e1618) used to capture metal poisoning and blood heavy metal increased and unspecified tissue injury (e2015) used to capture soft tissue injury and bone injury.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.On (b)(6) 2008 the patient had a left total hip replacement to address left hip osteoarthritis.Depuy components were implanted during this procedure, which included depuy cup, metal liner, articlul/eze femoral head, and summit stem.On (b)(6) 2022 the patient had a revision left total hip arthroplasty to address pseudotumor, pain and weakness along with elevated ion levels.The surgeon observed copious amounts of metal-stained fluid and metallosis in the joint.There was a large pseudotumor as well.The surgeon also observed osteolysis.The surgeon did an extended osteotomy to remove the stem.Cables were utilized to secure the osteotomy site.During the procedure the surgeon implanted pinnacle dual mobility liner bi-mentum for a 56 cup, 49 mm liner, articul/eze head with the associated bi-mentum pe liner, reclaim distally tapered stem and a proximal body.

• 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: 16564229
• MDR Text Key: 311488332
• Report Number: 1818910-2023-06081
• 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
• Report Date: 03/17/2023

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?: 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: 03/01/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 08/04/2023
• 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 LINER METAL PINNACLE.; UNK HIP FEMORAL HEAD METAL.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR