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

Catalog Number 4845-4-410

Device Problems Corroded (1131); Device-Device Incompatibility (2919)

Patient Problem Pain (1994)

Event Date 08/11/2011

Event Type  Injury  

Manufacturer Narrative

This event was previously reported under rae 2013-004.This report will document additional information received.Reported event: an event regarding pain 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 pain is considered to be under the scope of this recall.No further investigation is required.Corrective action: ncr was initiated on 28-mar-2012 because the occurrence rate for adverse local tissue reaction (altr) specified in the risk management files for the abgii modular hip system was exceeded.Given the potential risk of fretting and corrosion with these devices, voluntary product recall ra 2012-067 was issued.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.

Event Description

Patient has filed a claim related to abgii modular devices.Update per legal: it was reported through the filing of a lawsuit that allegedly the plaintiff underwent a right total hip arthroplasty on (b)(6) 2011 and was implanted with a abg ii modular hip system.It is further alleged that the plaintiff began to experience pain and elevated metal ion levels, plaintiff has not yet scheduled revision surgery.Additional information received from sales rep on 9/9/2020: it was reported that the patient's right hip was revised after patient complaint of pain.Intra-operatively, corrosion was noted at the stem/ neck junction.The stem and ceramic head were revised to competitor devices.Rep confirmed there are no allegations against the revised ceramic head, and that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Updated patient information, manufacturing and expiration date.Reported event: an event regarding revision due to corrosion and abnormal ion level 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: no medical records were received for review with a clinical consultant.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 pain is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned.

Event Description

Patient has filed a claim related to abgii modular devices.Update per legal.It was reported through the filing of a lawsuit that allegedly the plaintiff underwent a right total hip arthroplasty on (b)(6) 2011 and was implanted with a abg ii modular hip system.It is further alleged that the plaintiff began to experience pain and elevated metal ion levels, plaintiff has not yet scheduled revision surgery.Additional information received from sales rep on 9/9/2020: it was reported that the patient's right hip was revised after patient complaint of pain.Intra-operatively, corrosion was noted at the stem/ neck junction.The stem and ceramic head were revised to competitor devices.Rep confirmed there are no allegations against the revised ceramic head, and that no further information will be released by the hospital or surgeon.

• 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: 10655850
• MDR Text Key: 210641773
• Report Number: 0002249697-2020-02097
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 4845-4-410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RA 2012-067
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR