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

Catalog Number 4845-4-104

Device Problem Device-Device Incompatibility (2919)

Patient Problems Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.Although the reported device is considered to be under the scope of this recall, the reported failure mode is not.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 customer reported that: "i would like to inform you that we have made a material vigilance declaration concerning an abg ii total hip prosthesis, fitted in 2011 and removed on (b)(6) 2021 because of the presence of a collection at its contact.".

Manufacturer Narrative

Reported event: an event regarding infection 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 been other events for the reported lot and no other events for sterile lot.Similar events have occurred for the catalog number and product family.These events were determined to be associated with (b)(4).Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device 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

The customer reported that: "i would like to inform you that we have made a material vigilance declaration concerning an abg ii total hip prosthesis, fitted in 2011 and removed on (b)(6) 2021 because of the presence of a collection at its contact.".

• 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
• MDR Report Key: 12352826
• MDR Text Key: 267633090
• Report Number: 0002249697-2021-01440
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 4845-4-104
• Device Lot Number: G3035469
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2089-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention