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

Catalog Number 4845-4-411

Device Problem Device-Device Incompatibility (2919)

Patient Problem Pain (1994)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

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.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.Similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.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

Legal case involving a right tha revision surgery on stryker products with a hazard alert/recall."(b)(6) 2019, when dr advised that the plaintiff required extraction of the implants with surgical debridement in a staged procedure, due to increasing pain in both hips as well as the left calf and sciatic nerve.On (b)(6) 2020, dr opined that the acute neurological changes that the plaintiff was suffering were "potentially.Related to the modular tapered junction of the femoral component".On (b)(6) 2020, the plaintiff underwent stage 1 revision of the revision total hip replacement during which abg ii femoral stem with ceramic head removed.On (b)(6) 2020 the plaintiff underwent stage 2 of the revision procedure." it should be noted that latter revision surgeries did not involve stryker products.

Event Description

Legal case involving a right tha revision surgery on stryker products with a hazard alert/recall."(b)(6) 2019, when dr advised that the plaintiff required extraction of the implants with surgical debridement in a staged procedure, due to increasing pain in both hips as well as the left calf and sciatic nerve.On (b)(6) 2020, dr opined that the acute neurological changes that the plaintiff was suffering were "potentially.Related to the modular tapered junction of the femoral component".On (b)(6) 2020, the plaintiff underwent stage 1 revision of the revision total hip replacement during which abg ii femoral stem with ceramic head removed.On (b)(6) 2020 the plaintiff underwent stage 2 of the revision procedure." it should be noted that latter revision surgeries did not involve stryker products.

Manufacturer Narrative

Reported event: an event regarding revision due to 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: not performed as no lot was provided.-complaint history review: a search of the complaint databases could not be performed as lot code information was not provided.Similar events have occurred for the rejuvenate modular 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 pain, metal in blood stream, infection, discoloration of tissues 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, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17599378
• MDR Text Key: 321692599
• Report Number: 0002249697-2023-00918
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4845-4-411
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2089-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male