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 Degraded (1153); Device-Device Incompatibility (2919)

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

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

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 event is considered to be under the scope of this recall.No further investigation is required.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.H3 other text : device not returned.

Event Description

Patient had a primary right hip implant in 2010 and reported pain in groin and feeling of hip "giving out".Patient stated he received a letter in 2011 that his implants were subject to a recall but he was not having any issues at that time.Update per conversation with patient (b)(6) 2023: patient reported swelling, "funny taste in mouth" and two "masses" near kidney and liver.

Event Description

Patient had a primary right hip implant in 2010 and reported pain in groin and feeling of hip "giving out".Patient stated he received a letter in 2011 that his implants were subject to a recall but he was not having any issues at that time.Update per conversation with patient (b)(6) 2023: patient reported swelling, "funny taste in mouth" and two "masses" near kidney and liver.

Manufacturer Narrative

Reported event: an event regarding involving an pain was reported.The event was confirmed.Method & results: -product evaluation and results: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-clinician review: conclusion of assessment: this product inquiry concerns a patient who underwent a modular neck femoral prosthesis, abg ii with a cobalt chrome femoral head in 2010.The patient developed symptoms of a funny taste in his mouth and he reported to masses near his kidney and liver.The implant was voluntarily recalled by stryker because of the possibility of fretting and corrosion and trunnionosis.I can confirm that the patient had the primary procedure since i was able to see the original stryker stickers.No other clinical information is provided.If the patient is having metallosis/trunnionosis, then the root cause cannot be determined with certainty.The root cause of this event is multifactorial including surgical technique factors, patient factors including the patient's activity level and bmi and implant factors.If this patient comes to revision, the explanted prostheses should be submitted to stryker engineers for evaluation and metallurgical examination.-product history review: lot id there have been no other events reported for the lot code -complaint history review: could not be performed as the device lot details were not provided.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 event 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18369781
• MDR Text Key: 331047424
• Report Number: 0002249697-2023-01582
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 4845-4-415
• Device Lot Number: G2938719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2009
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 122 KG