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

Catalog Number 4845-4-205

Device Problem Device-Device Incompatibility (2919)

Patient Problems Unspecified Infection (1930); Metal Related Pathology (4530)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding infection and corrosion 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 or sterile lot. Similar events have occurred for the catalog number and product family. These events(infection, corrosion) were determined to be associated with ra 2012-067. 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. 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 infection and corrosion are considered to be under the scope of this recall. No further investigation is required. Device not returned to the manufacturer.

Event Description

It was reported a stage 1 revision was performed on the patient's right hip due to infection. Intra-operatively, surgeon reported that the cup 'spun out' and that there was corrosion at the stem/ neck junction of the modular stem. All components were removed and a spacer was placed.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13205507
• MDR Text Key: 288699916
• Report Number: 0002249697-2022-00048
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 4845-4-205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 01/10/2022 Patient Sequence Number: 1