MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ABG II STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problem Device-Device Incompatibility (2919)

Patient Problems Cardiomyopathy (1764); Foreign Body Reaction (1868); Menstrual Irregularities (1959); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/01/2022

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 levels is considered to be under the scope of this recall.No further investigation is required.Although no catalog number or lot code was provided, similar events have occurred for the product family.These events were determined to be associated with ra 2012-067.H3 other text : device not returned to the manufacturer.

Event Description

"i am a patient who was implanted with the abg ii hip prosthesis in 2013.Following the use of this medical device, i have experienced numerous health problems such as autoimmune hemolytic anemia, hypothyroidism, premature menopause, ovarian failure, heart failure, cardiomyopathy, sensorineural deafness and atopic dermatitis.I performed revisions in 2019 & 2020 and the only remaining part of the implanted prosthesis in 2013 was the stem of the abg ii prosthesis.During the recent revision in 2023, it was necessary to remove this remaining part of the prosthesis.This discovery was made in (b)(6) 2022, when it was found that i was exposed to high levels of cobalt, with a maximum value of 1550.I found out that the abg ii prothesis was recalled in 2012 and then implanted to me in 2013.".

• Brand Name: UNKNOWN ABG II STEM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18491150
• MDR Text Key: 332610886
• Report Number: 0002249697-2024-00064
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Female