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

Catalog Number 4845-4-202

Device Problem Device-Device Incompatibility (2919)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 12/16/2023

Event Type  Injury  

Manufacturer Narrative

Complaint history review: the complaint databases show there have been no similar 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.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 pain is considered to be under the scope of this recall.No further investigation is required.H3 other text : not returned to the manufacturer.

Event Description

The customer reported: "date of implantation : (b)(6) 2010.Date of explantation : 16/12/2023" "incident information : date of occurrence: 16/12/2023.Incident description: acute loosening of the trident acetabulum on abg ii fitted 13 years ago.Observation of metallosis, a pretetrochanteric pseudotumour and a muscular lesion.As well as a significant muscular lesion of the gluteus medius.Patient information: patient's current condition: change of thp for a complete future + metaphyseal cerclage.Post-operative course simple, pain relieved by usual analgesics, satisfactory control x-ray, clean, non-inflammatory scar.Inflammatory.The patient was able to get up and walk around with the help of the physiotherapists without any difficulty.Actions taken in the healthcare establishment to manage the patient: ansm declaration + preservation of the dm + information from the manufacturer/laboratory".

Manufacturer Narrative

An event regarding altr 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.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 altr is considered to be under the scope of this recall.No further investigation is required.

Event Description

The customer reported: "date of implantation : (b)(6) 2010.Date of explantation : (b)(6) 2023"."incident information : date of occurrence: (b)(6) 2023.Incident description: acute loosening of the trident acetabulum on abg ii fitted 13 years ago.Observation of metallosis, a pretetrochanteric pseudotumour and a muscular lesion.As well as a significant muscular lesion of the gluteus medius.Patient information: patient's current condition: change of thp for a complete future + metaphyseal cerclage.Post-operative course simple, pain relieved by usual analgesics, satisfactory control x-ray, clean, non-inflammatory scar.Inflammatory.The patient was able to get up and walk around with the help of the physiotherapists without any difficulty.Actions taken in the healthcare establishment to manage the patient: ansm declaration + preservation of the dm + information from the manufacturer/laboratory".

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18562082
• MDR Text Key: 333444168
• Report Number: 0002249697-2024-00122
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 4845-4-202
• Device Lot Number: G2656555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2009
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White