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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS CORP MAHWAH ABG II NO 5 CEMENTLESS LEFT V40 IMPLANT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS CORP MAHWAH ABG II NO 5 CEMENTLESS LEFT V40 IMPLANT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Model Number ABGII NO5 CEMENTLESS
Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)
Patient Problems Cyst(s) (1800); Skin Discoloration (2074); Osteolysis (2377); Pericarditis (4448); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Event Date 02/15/2013
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 orthopaedics-mahwah abg ii no 5 cementless left v40. Afterwords, 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 (b)(6) 2013 (which i can send if requested). Fda safety report id # (b)(4).
 
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Brand NameMAHWAH ABG II NO 5 CEMENTLESS LEFT V40 IMPLANT
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS CORP
mahwah NJ 07430
MDR Report Key11817494
MDR Text Key250988562
Report NumberMW5101330
Device Sequence Number1
Product Code MEH
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date03/31/2013
Device Model NumberABGII NO5 CEMENTLESS
Device Catalogue Number4845-0205
Device Lot NumberG2171408G
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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