MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS CORP. STRYKER ORTHOPAEDICS-MAHWAH ABGII NO5 CEMENTLESS LEFT V40 IMPLANT; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 4845-0205

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Skin Discoloration (2074); Osteolysis (2377); Swollen Lymph Nodes/Glands (4432); Pericarditis (4448); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Solid Tumour (4552)

Event Date 03/04/2013

Event Type  Injury  

Event Description

I am the patient related to the fda report: stryker orthopaedics-mahwah abg ii no 5 cementless left v40 catalog number 4845-0205 event date (b)(6) 2013 mdr report key (b)(4) mdr text key (b)(4) this is the prosthesis that was put on me: stryker orthopedics-mahwah abg ii no 5 cementless left v40.Afterwards, two ct scans, one performed on (b)(6) 2013 and the other ¿ resolutive - on (b)(6) 2013, showed that the prosthesis was badly positioned and for this reason an impingement had been caused between the stem and the acetabular cup (including polyethylene insert).The acetabular cup had been implanted with poor anteversion: the anteversion angle of 20 ° was not respected and it was only 7 °.This fact had injured the iliopsoas tendon, which has never recovered, even after the removal and replacement of the prosthesis.The tests to which stryker refers in the report of the case , were only nickel and chromium because stryker on (b)(6) 2013 had not yet provided the doctor who had made the report, the technical data sheet of the prosthesis, where all the metals to be searched were indicated.Actually, i have the email in which stryker confirms the opening of the accident in my name and sends the data sheet to my trusted orthopedist.On (b)(6) 2013 i already had exams, with all prosthetic metals in high/ toxic concentrations in the body.Titanium increased again until the last examination on (b)(6) 2013.On (b)(6) 2013 the prosthesis was explanted and strong osteolysis was found due to metallosis and damage from polyethylene and metal debris (metal particles) were found on the psoas tendon and in the periprosthetic tissues.The consequences i have developed have been: - thyroid nodules, pericarditis, in 2015 appeared a spot similar to acanthosis nigricans of considerable size; in 2016 a 12 cm pelvic pseudotumor containing the prosthetic metals titanium etc., was removed, titanium etc.Were found in the pleural fluid and in the abdominal fluid - in 2016 removal of sub-mammary nevus for suspected melanoma and skin spot biopsy.The histological examination confirmed adverse reaction to foreign bodies, including in mammary cysts (2017); atrophy of iliopsoas.The values of titanium and other prosthetic metals are further increased until the explantation of the prosthesis ((b)(6) 2013), as from the report dated 20 july 2013 (which i can send if requested).Fda safety report id# (b)(4).

• Brand Name: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO5 CEMENTLESS LEFT V40 IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS CORP.
• MDR Report Key: 11805925
• MDR Text Key: 250883982
• Report Number: MW5101277
• Device Sequence Number: 1
• Product Code: KWY
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 4845-0205
• Device Lot Number: G2171408G
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 64