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

Catalog Number 4845-4-105

Device Problems Fracture (1260); Device-Device Incompatibility (2919)

Patient Problems Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 02/07/2023

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.

Event Description

The following was reported: "a patient was operated on in (b)(6) 2007 for hip coxarthrosis.This patient received abg implants.Unfortunately, the femoral implant broke at the level of the female impression of the modular cone, which necessitated the complete replacement of the implants on the (b)(6) of (b)(6) 2023.".

Manufacturer Narrative

Reported event: an event regarding metallosis and fracture of femoral stem component involving a abgii modular device was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: visual inspection of the returned device indicated damage consistent with explantation.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there been no 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.Clinical review ; a review of the provided medical records stated that : patient was revised due to fracture of the femoral implant.The intra-operative findings from the revision surgery included gross metallosis med and the fracture of the most proximal portion of the femoral stem.Fracture of a femoral stem component is confirmed.The root cause of this fracture cannot be identified from this limited documentation.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 altr is considered to be under the scope of this recall.No further investigation is required.

Event Description

The following was reported: "a patient was operated on in november 2007 for hip coxarthrosis.This patient received abg implants.Unfortunately, the femoral implant broke at the level of the female impression of the modular cone, which necessitated the complete replacement of the implants on the (b)(6) 2023.".

• Brand Name: ABGII. MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: 16538586
• MDR Text Key: 311243829
• Report Number: 0002249697-2023-00257
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2011
• Device Catalogue Number: 4845-4-105
• Device Lot Number: G1618435H6L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2006
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 81 KG