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

Catalog Number 4845-4-106

Device Problem Material Erosion (1214)

Patient Problem Foreign Body Reaction (1868)

Event Date 04/05/2022

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 pain and elevated ion levels is considered to be under the scope of this recall.No further investigation is required.Similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.

Event Description

This pi is for the right hip.The patient's attorney reports the following situation: in 2009, the patient had left and right artificial hip joints implanted.During an orthopedic check-up in early (b)(6) 2022, the patient was informed by his orthopedist that he was aware of quality deficiencies in hip prosthesis products from the stryker company and was advised to undergo a blood test.A blood test was then carried out on the patient, which in fact revealed significantly higher levels of cobalt and chromium, giving rise to the justified suspicion of a product defect.The lawyer requests stryker to bindingly notify known quality defects with regard to the product batches used with the patient as well as the responsible manufacturer in accordance with the product liability act within one month of receipt of this letter.The implantation of the right hip took place on (b)(6) 2009.

Manufacturer Narrative

Reported event: 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 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 (b)(6) conclusions voluntary recall (b)(4) 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.

Event Description

This pi is for the right hip.The patient's attorney reports the following situation: in 2009, the patient had left and right artificial hip joints implanted.During an orthopedic check-up in early april 2022, the patient was informed by his orthopedist that he was aware of quality deficiencies in hip prosthesis products from the stryker company and was advised to undergo a blood test.A blood test was then carried out on the patient, which in fact revealed significantly higher levels of cobalt and chromium, giving rise to the justified suspicion of a product defect.The lawyer requests stryker to bindingly notify known quality defects with regard to the product batches used with the patient as well as the responsible manufacturer in accordance with the product liability act within one month of receipt of this letter.The implantation of the right hip took place on (b)(6) 2009.

• Brand Name: ABGII. MODULAR 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15628270
• MDR Text Key: 301977477
• Report Number: 0002249697-2022-01513
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Catalogue Number: 4845-4-106
• Device Lot Number: G2000518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2007
• 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
• Patient Age: 69 YR
• Patient Sex: Male