MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO7 CEMENTLESS RIGHT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	4845-0107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	03/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.H3 other text : device not returned.
Event or Problem Description
The following was reported: broken abg ii stem.Abg stem was broken when implant was in situ, because the stem was broken the patient needs to be revised.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an abgii stem was reported.The event was confirmed via evaluation of the device and clinician review of the provided medical records.Method & results: -product evaluation and results: images shows the abg ii stem with fracture location highlighted.On visual examination, the fracture was observed through the neck of the stem.Stereo microscope imaging was performed on both the proximal and distal fracture surfaces, respectively.Based on macroscopic surface features observed, including river lines, the approximate location of origin (o) and direction of propagation (p) were determined.The final fracture location (f) is also identified and labelled.The macroscopic surface features observed on the fracture surface indicate the component fracture propagated in fatigue.Figures show explantation damage around the neck of the stem.Figures show surface material damage around the mid-stem region, near the blast surface.These indications were likely a result of third-body damage and micromotion effects due to cement mantle breakdown.Figures show bone growth on the scales region of the stem.Material analysis was performed that indicated " characterization using stereo microscopy and scanning electron microscopy confirmed fracture through the neck of the stem.The fracture was observed to have propagated in fatigue with final fracture in overload.No manufacturing or material related defects were observed on the device surfaces examined.-clinician review: a review of the provided medical information by a clinical consultant indicated: there is evidence of loss of fixation of the acetabular component with revision to a pressfit cup with bone graft and mesh in the supra- acetabular region.There is also evidence of stem fracture through the trunnion.Loss of fixation of a pressfit acetabular component and subsequent fracture of the trunnion of the femoral component is confirmed.The root cause of these mechanical failures cannot be determined from the limited documentation provided.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the stem.Material analysis was performed that indicated " characterization using stereo microscopy and scanning electron microscopy confirmed fracture through the neck of the stem.The fracture was observed to have propagated in fatigue with final fracture in overload.No manufacturing or material related defects were observed on the device surfaces examined.A review of the provided medical information by a clinical consultant indicated: there is evidence of loss of fixation of the acetabular component with revision to a pressfit cup with bone graft and mesh in the supra- acetabular region.There is also evidence of stem fracture through the trunnion.Loss of fixation of a pressfit acetabular component and subsequent fracture of the trunnion of the femoral component is confirmed.The root cause of these mechanical failures cannot be determined from the limited documentation provided.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.
Event or Problem Description
The following was reported: broken abg ii stem.Abg stem was broken when implant was in situ, because the stem was broken the patient needs to be revised.

• Brand Name: ABGII NO7 CEMENTLESS RIGHT 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 19001230
• Report Number: 0002249697-2024-00522
• Device Sequence Number: 8501840
• Product Code: LPH
• UDI-Device Identifier: 07613327050974
• UDI-Public: 07613327050974
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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 Expiration Date: 04/30/2014
• Device Catalogue Number: 4845-0107
• Device Lot Number: G2687983D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2009
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 150 KG