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

Catalog Number UNK_SHC

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

Patient Problems Cardiomyopathy (1764); Foreign Body Reaction (1868); Menstrual Irregularities (1959); Heart Failure/Congestive Heart Failure (4446); Metal Related Pathology (4530)

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.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.".

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving an unknown shell was reported.The event was not confirmed.Method & results:  device evaluation and results: not performed as product was not returned.  clinician review: a review of the provided medical records by a clinical consultant indicated: confirmation of event: i can indirectly confirm that patient had the primary total hip arthroplasty since many references are made to the initial procedure and i was able to see explanted necrotic/metallosis material and the acetabular cup, ceramic liner, and ceramic head.No dates were placed on the video or the photograph of the explanted material.I do not have specific operation reports for the primary procedure or any of the revision procedures.Root cause analysis: assuming that the patient developed metallosis and elevated metal ion levels with subsequent systemic manifestations, the root cause cannot be determined with certainty.Causes of metallosis with elevated ion levels are multifactorial including surgical technique, especially in the way that the trunnion and modular surfaces are prepared, assembled, and implanted, patient factors including activity level and bmi and implant factors.Device history review: could not be performed as lot code information was not provided.  complaint history review: could not be performed as lot code information was not provided.  conclusion: a review of the provided medical records by a clinical consultant indicated: confirmation of event: i can indirectly confirm that patient had the primary total hip arthroplasty since many references are made to the initial procedure and i was able to see explanted necrotic/metallosis material and the acetabular cup, ceramic liner, and ceramic head.No dates were placed on the video or the photograph of the explanted material.I do not have specific operation reports for the primary procedure or any of the revision procedures.Root cause analysis: assuming that the patient developed metallosis and elevated metal ion levels with subsequent systemic manifestations, the root cause cannot be determined with certainty.Causes of metallosis with elevated ion levels are multifactorial including surgical technique, especially in the way that the trunnion and modular surfaces are prepared, assembled, and implanted, patient factors including activity level and bmi and implant factors.The exact cause of the event could not be determined because insufficient information was provided.Additional information including device identification, return of the device, office notes, pre and post operative notes are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

On april 3, 2024: update based on medical records: based on additional information, the abg monolithic femoral stem remained implanted during the 2019 revision.It is unknown if the acetabular devices explanted in 2019 were stryker product so a pi will not be created for the 2019 revision.It was also discovered that in 2020 the patient had a revision of a stryker alumina liner and acetabular shell.Therefore another pi will be updated to cover the patient's revision in 2020 of a stryker acetabular shell and alumina ceramic liner.The patient reported via general email address of the distribution site the following: "i am a patient who was implanted with the abg ii hip prosthesis in 2013.Recently, i discovered that this model was withdrawn from the market in 2012 and was included in a recall.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 and 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, unaware of this.I would like to initiate a discussion with you to explore the possibilities of compensation for expenses incurred for surgery, treatment and other costs related to this situation.I am open to working together to find a fair solution in this matter.I look forward to your response and the opportunity to discuss this matter in more detail, but i am also at your disposal with any further information you may require in relation to this case.".

• Brand Name: UNKNOWN ABG II 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18491149
• MDR Text Key: 332610423
• Report Number: 0002249697-2024-00065
• 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,Followup
• Report Date: 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/21/2024
• 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 Age: 25 YR
• Patient Sex: Female