MAUDE Adverse Event Report: STRYKER/HOWMEDICA OSTEONICS CORP TRIDENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Lot Number 7730P7

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 12/20/2021

Event Type  Injury  

Event Description

Patient was revised was due to heavy metal poisoning from toxic heavy metals.Also alleges injury, pain, tissue destruction, metal wear, loss of enjoyment of life and limitation of daily activities.Complaint number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRIDENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER/HOWMEDICA OSTEONICS CORP
• MDR Report Key: 17488488
• MDR Text Key: 320685534
• Report Number: MW5121187
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 7730P7
• Patient Sequence Number: 1