MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII. MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 4845-4-104

Device Problem Device-Device Incompatibility (2919)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Metal Related Pathology (4530)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.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.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 metallosisis considered to be under the scope of this recall.No further investigation is required.Not available.

Event Description

The lawyer reported that the patient underwent a total right hip atroprosthesis on (b)(6) 2011 at the villa stuart clinic in rome with abgii mod.And discharged on (b)(6) 2011.Although the patient diligently followed the prescribed post-operative therapy, there was never a recovery and her condition progressively worsened.The patient lived for years with severe coxalgia and with very serious limitations on the prosthetic joint.Only in the early 2020 through radiological and laboratory investigations, they gave evidence of an adverse reaction to the metals of the implanted prosthesis (metallosis) with the development of pseudotumor in the right iliac fossa.The patient then had to undergo long periods of hospitalization and further surgery.On (b)(6) 2020 prosthesis explant surgery and antibiotic spacer positioning.On (b)(6) 2020 surgery to remove pseudotumor in the right iliac fossa.On (b)(6) 2020 intervention to remove spacer and revision implant.On (b)(6) 2020 debridement surgery with antibiotic pearls positioned.

Event Description

The lawyer reported that the patient underwent a total right hip atroprosthesis on (b)(6) 2011 at the villa stuart clinic in rome with abgii mod.And discharged on (b)(6) 2011.Although the patient diligently followed the prescribed post-operative therapy, there was never a recovery and her condition progressively worsened.The patient lived for years with severe coxalgia and with very serious limitations on the prosthetic joint.Only in the early 2020 through radiological and laboratory investigations, they gave evidence of an adverse reaction to the metals of the implanted prosthesis (metallosis) with the development of pseudotumor in the right iliac fossa.The patient then had to undergo long periods of hospitalization and further surgery (b)(6) 2020 prosthesis explant surgery and antibiotic spacer positioning.(b)(6) 2020 surgery to remove pseudotumor in the right iliac fossa.(b)(6) 2020 intervention to remove spacer and revision implant.(b)(6) 2020 debridement surgery with antibiotic pearls positioned.

Manufacturer Narrative

Reported event: an event regarding altr and metalosis involving a 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 altr and metalosis is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: ABGII. MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11294247
• MDR Text Key: 230757945
• Report Number: 0002249697-2021-00232
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 4845-4-104
• Device Lot Number: G3007908
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• 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: 65 YR