MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO4 CEMENTLESS LEFT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	4845-0204
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: total aseptic loosening.
Additional 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 or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding loosening involving an abg ii stem was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant.Indicated: conclusion of assessment: confirmation of event: i can confirm that the patient had a primary cementless total hip arthroplasty at some point in the past because i was able to see an x-ray with the implant in place.I can also confirm that the x-rays were consistent with at least acetabular loosening.I cannot confirm the revision surgery since i have no documentation of the surgery or post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of a cementless total hip arthroplasty 7 years postoperatively are multifactorial including original surgical technique assuring proper sizing, fit and stability, local host bone factors such as osteopenia, and patient factors including lifestyle, activity level and bmi.With the information provided i would not assign any causality to the implant itself.-product history review: review of the device history records could not be completed due to insufficient information.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due stem loosening.A review of the provided medical records by a clinical consultant indicated: conclusion of assessment: confirmation of event: i can confirm that the patient had a primary cementless total hip arthroplasty at some point in the past because i was able to see an x-ray with the implant in place.I can also confirm that the x-rays were consistent with at least acetabular loosening.I cannot confirm the revision surgery since i have no documentation of the surgery or post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of a cementless total hip arthroplasty 7 years postoperatively are multifactorial including original surgical technique assuring proper sizing, fit and stability, local host bone factors such as osteopenia, and patient factors including lifestyle, activity level and bmi.With the information provided i would not assign any causality to the implant itself.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ABGII NO4 CEMENTLESS LEFT V40
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21525012
• Report Number: 0002249697-2025-00271
• Device Sequence Number: 18531983
• Product Code: LPH
• UDI-Device Identifier: 07613327051025
• UDI-Public: 07613327051025
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4845-0204
• Device Lot Number: GY424646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown