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

Catalog Number 4845-4-410

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. ".

• Brand Name: ABGII MODULAR SHORT NECK
• 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: 12352811
• MDR Text Key: 267632070
• Report Number: 0002249697-2021-01441
• 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,other
• Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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

• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 4845-4-410
• Device Lot Number: G3053243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2011
• 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 Treatment Data

Date Received: 08/23/2021 Patient Sequence Number: 1