MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII MODULAR SHORT NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 4845-4-412

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been 3 other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Doctor reported the following event to (b)(4) : "a (b)(6) patient hospitalized for a total hip replacement.Discovery of a (b)(6) infection, complicated by secondary locations (perirachideal abscess and ilio-psoas muscles).This prosthesis was implanted on (b)(6) 2009.It is an abgii modular modular prosthesis associated with risks of release of metal ions and debris.The prosthesis was explanted.A pulsed washing of the operative site was performed and a cement spacer was laid.The patient was transferred to intubated and ventilated surgical resuscitation, due to intraoperative hemodynamic instability.The bleeds required a heterologous transfusion.Functional deficit before considering the implantation of another total hip prosthesis.The devices were not kept for expertise.

Event Description

Doctor reported the following event to french ca ansm : "a 77-year-old patient hospitalized for a total hip replacement.Discovery of a staphylococcus aureus infection, complicated by secondary locations (perirachideal abscess and ilio-psoas muscles).This prosthesis was implanted on (b)(6) 2009.It is an abgii modular modular prosthesis associated with risks of release of metal ions and debris.The prosthesis was explanted.A pulsed washing of the operative site was performed and a cement spacer was laid.The patient was transferred to intubated and ventilated surgical resuscitation, due to intraoperative hemodynamic instability.The bleeds required a heterologous transfusion.Functional deficit before considering the implantation of another total hip prosthesis.The devices were not kept for expertise.

Manufacturer Narrative

An event regarding revision due to infection involving an abgii modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Clinician review: the provided medical information was submitted to a consulting clinician who indicated that: "on (b)(6) 2017, a revision right hip prosthesis was performed for a diagnosis of ¿sepsis on right hip prosthesis x-ray printouts available for review include a series dated on (b)(6) 2017 and are two aps of the right hip demonstrating the proximal femur absent from the level of the neck and the acetabulum is filled with a radio dense cement bolus.No examination of explanted components, no surgical histopathology or description of metalosis at revision surgery, and no serum ion determinations are available for review there is no evidence this periprosthetic total hip arthroplasty infection was related to factors of implant design, manufacturing or materials." device history review: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have been other events for the reported lot.Similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.Conclusions: it was reported staphylococcus aureus infection was discovered.The provided medical information was submitted to a consulting clinician who indicated that patient was revised for a diagnosis of sepsis.No examination of explanted components, no surgical histopathology or description of metalosis at revision surgery, and no serum ion determinations are available for review.There is no evidence this periprosthetic total hip arthroplasty infection was related to factors of implant design, manufacturing or materials.Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported revision due to infection is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: ABGII MODULAR SHORT NECK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7152054
• MDR Text Key: 95959869
• Report Number: 0002249697-2017-03752
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

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: 10/11/2012
• Device Catalogue Number: 4845-4-412
• Device Lot Number: G1887592
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2089/2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 135