MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF SIZE 4 HIGH OFFSET STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2021

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

It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, trunnionosis, trummion wear, and liner damage due to dissociation were noted.

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

It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, trunnionosis, trummion wear, and liner damage due to dissociation were noted.

Manufacturer Narrative

Reported event: an event regarding disassociation involving an unknown accolade stem was reported.The event was confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that the trunnion of the stem is significantly worn.Damage is consistent with loss of taper lock.The device appears recently explanted with blood/tissue on the surfaces visible.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry reports the failure of a total hip replacement about 11 years after implantation for trunnion wear and disassociation.I can confirm that trunnion wear and disassociation took place since i was able to view xrays showing the issue.I cannot confirm revision since i have no documentation such as an operation report or post revision xrays.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion wear and disassociation are multifactorial including surgical technique factors, patient factors, and implant factors." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to disassociation of the head from the stem and associated trunnion wear.The event was confirmed by medical review and visual inspection of the device photographs provided.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, the primary and revision operative reports, and patient history and follow-up notes are needed to complete the investigation for determining root cause.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 Description

It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, trunnionosis, trummion wear, and liner damage due to dissociation were noted.

• Brand Name: UNKNOWN ACCOLADE TMZF SIZE 4 HIGH OFFSET 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13188921
• MDR Text Key: 286047828
• Report Number: 0002249697-2022-00035
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• 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: 03/29/2022
• 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 Age: 80 YR
• Patient Sex: Male