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

Catalog Number 4845-4-415

Device Problems Material Erosion (1214); Device-Device Incompatibility (2919)

Patient Problems Foreign Body Reaction (1868); Synovitis (2094)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported 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 abgii.Modular stem is considered to be under the scope of this recall.No further investigation is required.

Event Description

Customer reported us the following information: "this e-mail is to inform you of a new event related to material safety concerning the abg ii hip prosthesis.A declaration to the ansm has been made today.The prosthesis was implanted on (b)(6) 2010 on the left side.Regular monitoring has been carried out for 10 years following material vigilance and a deterioration has been observed for 10 years.The patient is (b)(6), 89 kg, 169 cm.Prosthesis fitted and explanted by dr.On opening on (b)(6) 2021, the implant was well fixed but synovitis and a strong effusion were observed.Metallosis was also observed.The prosthesis was changed.At the biological level, there was no increase in chromium and cobalt.".

Manufacturer Narrative

Reported event: an event regarding metallosis 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 metallosis is considered to be under the scope of this recall.No further investigation is required.

Event Description

Customer reported us the following information: "this e-mail is to inform you of a new event related to material safety concerning the abg ii hip prosthesis.A declaration to the ansm has been made today.The prosthesis was implanted on (b)(6) 2010 on the left side.Regular monitoring has been carried out for 10 years following material vigilance and a deterioration has been observed for 10 years.The patient is 60 years old, 89 kg, 169 cm.Prosthesis fitted and explanted by dr.On opening on (b)(6) 2021, the implant was well fixed but synovitis and a strong effusion were observed.Metallosis was also observed.The prosthesis was changed.At the biological level, there was no increase in chromium and cobalt.".

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12708465
• MDR Text Key: 278836255
• Report Number: 0002249697-2021-01779
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 4845-4-415
• Device Lot Number: G3005810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 89 KG