MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO5 CEMENTLESS LEFT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	4845-0205
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	10/30/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported in medwatch mw5101277: "i am the patient related to the fda report: stryker orthopaedics-(b)(4) abg ii no.5 cementless left v40 catalog number 4845-0205 event date (b)(6) 2013 mdr report key (b)(4).This is the prosthesis that was put on me: stryker orthopedics-(b)(4) 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 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).Update as per received medwatch mw5101330: i am the patient related to the fda report: stryker orthopaedics-(b)(4) 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-(b)(4) 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) 20131 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).

• Brand Name: ABGII NO5 CEMENTLESS LEFT V40
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12061525
• Report Number: 0002249697-2021-01074
• Device Sequence Number: 17143758
• Product Code: LPH
• UDI-Device Identifier: 07613327051032
• UDI-Public: 07613327051032
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: 4845-0205
• Device Catalogue Number: 4845-0205
• Device Lot Number: G2171408G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention