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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS CORP. STRYKER ORTHOPAEDICS-MAHWAH ABGII NO5 CEMENTLESS LEFT V40 IMPLANT PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
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).
 
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Brand NameSTRYKER ORTHOPAEDICS-MAHWAH ABGII NO5 CEMENTLESS LEFT V40 IMPLANT
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS CORP.
MDR Report Key11805925
MDR Text Key250883982
Report NumberMW5101277
Device Sequence Number1
Product Code KWY
Reporter Country CodeIT
Number of Events Reported1
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 Received05/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2013
Device Catalogue Number4845-0205
Device Lot NumberG2171408G
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/10/2021 Patient Sequence Number: 1
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