MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO4 CEMENTLESS RIGHT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 4845-0104

Device Problems Corroded (1131); Material Integrity Problem (2978)

Patient Problems Injury (2348); Fibrosis (3167)

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding alleged "patient factors leading to corrosion" involving an abg stem was reported.The event was confirmed.-medical records received and evaluation: the medical records were reviewed by the consulting clinician and indicated "no clinical or past medical history, no operative reports, and no serial x-rays, mri or ct images or reports are available for review.Based upon the information available for review, there is no evidence factors of faulty component design, manufacturing or materials were responsible for this clinical situation." -device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the reported device remains implanted.A review of the material analysis stated ".Eds showed the discoloration was consistent with a corrosion process, biological material and material transfer from a hip stem.No material or manufacturing defects were observed on the surfaces examined." the root cause of the reported event could not be confirmed as additional information such as clinical or past medical history, operative reports, serial x-rays, mri or ct images or reports are needed to complete the medical assessment.No further investigation is required at this time.If further information and/or device becomes available this investigation will be re-opened.

Event Description

It was reported, "patient had a reduction of range of motion due to a semi creamy mass (ivory color).The patient has been operated at in (b)(6) clinic in (b)(6) 2011.At 5 years control he arrived with limited range of motion due to a presence of swollen articulation and paresthesias of femoral nerve.He done mri, ct, eco which revealed presence of organized mass from the articulation to surrounding tissues.During surgery it was found high level of fibrosis and presence of yellowish-greyish material.There was clear sign of erosion at the internal surface of the head.It was substituted the head and the insert leaving stream (abgii) in the patient.".

• Brand Name: ABGII NO4 CEMENTLESS RIGHT V40
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6323249
• MDR Text Key: 67151379
• Report Number: 0002249697-2017-00535
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: 4845-0104
• Device Lot Number: G3058380D
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR