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

Catalog Number 4845-4-206

Device Problems Device Appears to Trigger Rejection (1524); Device-Device Incompatibility (2919)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Renal Impairment (4499)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, 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 chromium cobalt metal poisoning is considered to be under the scope of this recall.No further investigation is required.Device not returned.

Event Description

Discovery of acute renal failure.Total hip prosthetic implanted in 2011.Clinical surveillance dosage annual serum levels asymptomatic patient information: current status of the patient: kidney biopsy: chromium cobalt metal poisoning actions undertaken in the health care establishment for the care of the patient: removal of the prosthesis to be considered.

Manufacturer Narrative

Correction to the date of birth.Reported event: an event regarding abnormal ion level involving a 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 not 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.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.H3 other text : device not returned.

Event Description

Discovery of acute renal failure.Total hip prosthetic implanted in 2011.Clinical surveillance.Dosage annual serum levels.Asymptomatic patient.Patient information : current status of the patient : kidney biopsy: chromium cobalt metal poisoning.Actions undertaken in the health care establishment for the care of the patient: removal of the prosthesis to be considered.

• Brand Name: ABGII. MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11170658
• MDR Text Key: 226812593
• Report Number: 0002249697-2021-00115
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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 Expiration Date: 07/31/2014
• Device Catalogue Number: 4845-4-206
• Device Lot Number: G2853571
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR