MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ACCOLADE STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Degraded (1153); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 02/01/2024

Event Type  Injury  

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 Description

Right hip revision done today.The patient presented to the er with joint pain and felt a ¿pop¿.The explanted poly showed some superior wear.As per med review: x-rays revealed a head neck disassociation.

Event Description

Right hip revision done today.The patient presented to the er with joint pain and felt a ¿pop¿.The explanted poly showed some superior wear.As per med review: x-rays revealed a head neck disassociation.

Manufacturer Narrative

Reported event: an event involving an unknown accolade stem regarding disassociation and wear was reported.The event was confirmed.Method & results product evaluation and results: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral stem with signs of wear at the trunnion.Clinician review: this inquiry concerns a male patient who underwent a primary cementless total hip arthroplasty in 2011.Approximately 13 years later the patient became symptomatic and x-rays revealed a head neck disassociation.According to the product summary the patient underwent revision surgery where some polyethylene wear was noted.I can confirm that the patient underwent a primary right total hip arthroplasty since i was able to see x-rays with the implant in place along with the head neck disassociation.I cannot confirm the revision since i have no documentation including operation note, office notes, and post revision x-rays.The root cause of head neck disassociation in this case cannot be determined with certainty.Causes in general include surgical technique factors including trunnion preparation and proper head insertion, patient factors including activity level in bmi, and implant factors.The explanted prostheses should be submitted to stryker engineers for complete analysis and evaluation.Product history review: not performed as the lot number was not provided.Complaint history review: not performed as the lot number was not provided.Conclusions: it was reported that the patient was confirmed due to disassociation and wear.A review of the provided medical records by a clinical consultant indicated: "this inquiry concerns a male patient who underwent a primary cementless total hip arthroplasty in 2011.Approximately 13 years later the patient became symptomatic and x-rays revealed a head neck disassociation.According to the product summary the patient underwent revision surgery where some polyethylene wear was noted.I can confirm that the patient underwent a primary right total hip arthroplasty since i was able to see x-rays with the implant in place along with the head neck disassociation.I cannot confirm the revision since i have no documentation including operation note, office notes, and post revision x-rays.The root cause of head neck disassociation in this case cannot be determined with certainty.Causes in general include surgical technique factors including trunnion preparation and proper head insertion, patient factors including activity level in bmi, and implant factors.The explanted prostheses should be submitted to stryker engineers for complete analysis and evaluation." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN_ACCOLADE STEM
• Type of Device: 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: 18794505
• MDR Text Key: 336394696
• Report Number: 0002249697-2024-00307
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male