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); Pain (1994); Metal Related Pathology (4530)

Event Date 11/09/2023

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 elevated cobalt levels and 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 underwent left thr (b)(6) 2010.Abg ii modular hip system with an abg11 long neck, abg11 modular stem, and ceramic v40 femoral head 36mm were implanted.By 2014 patient was experiencing hip "squeaks" in deep flexion and blood investigations revealed raised cobalt levels.Patient reported left hip deterioration including on going pain & reduced walking capacity causing a limp.Revision surgery performed (b)(6) 2023.Patient reports constant pain over the left groin area.

Event Description

Patient underwent left thr (b)(6) 2010.Abg ii modular hip system with an abg11 long neck, abg11 modular stem, and ceramic v40 femoral head 36mm were implanted.By 2014 patient was experiencing hip "squeaks" in deep flexion and blood investigations revealed raised cobalt levels.Patient reported left hip deterioration including on going pain & reduced walking capacity causing a limp.Revision surgery performed (b)(6) 2023.Patient reports constant pain over the left groin area.

Manufacturer Narrative

An event regarding 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.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have been no 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 abnormal ion level is considered to be under the scope of this recall.No further investigation is required.

• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18264737
• MDR Text Key: 329667287
• Report Number: 0002249697-2023-01485
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092406
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: 4845-4-415
• Device Lot Number: G2850920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2009
• 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: 77 YR
• Patient Sex: Male