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

Catalog Number 4845-4-417

Device Problem Degraded (1153)

Patient Problems Calcium Deposits/Calcification (1758); Inflammation (1932); Pain (1994); Injury (2348); Depression (2361); Reaction (2414)

Event Date 09/24/2012

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been another events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.A voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.

Event Description

The lawyer reported that the patient has a dysplasia of the hip, bilateral coxarthrosis, for which he underwent a double intervention of arthroplasty on (b)(6) 2009 right hip.In 2011 due to the strong pains in the right hip, are found para-articular calcifications, so the patient was subjected to several sessions of infiltration.In (b)(6) 2012 the calcifications were removed surgically.On (b)(6) 2013 the patient underwent a revision surgery on the right hip.The patient is reported to have had synovial hyperplasia, metallosis, depression, unanticipated surgical procedure.

Manufacturer Narrative

An event regarding revision due to pain and metallosis 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.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 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 pain and metallosis is considered to be under the scope of this recall.No further investigation is required.

Event Description

The lawyer reported that the patient has a dysplasia of the hip, bilateral coxoartrosis, for which he underwent a double intervention of arthroplasty on (b)(6) 2009 right hip.In 2011 due to the strong pains in the right hip, are found para-articular calcifications, so the patient was subjected to several sessions of infiltration.In (b)(6) 2012 the calcifications were removed surgically.On (b)(6) 2013 the patient underwent a revision surgery on the right hip.The patient is reported to have had synovial hyperplasia, metallosis, depression, unanticipated surgical procedure.

• Brand Name: ABGII MODULAR LONG 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: 7215265
• MDR Text Key: 98085712
• Report Number: 0002249697-2018-00221
• 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: company representative,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 4845-4-417
• Device Lot Number: G2600917
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2089-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR