MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ACET WINDOW TRIAL 58MM; HIP TRIAL

Catalog Number 2208-2058

Device Problems Disassembly (1168); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

Trident window trial 58mm disassembled from the trial/cup inserter handle during acetabular preparation.The acetabulum was reamed to 58mm prior to trailing the 58mm window trial.The window trial treads were stripped so a bone tamp was used to mobilize the window trial and disengage it from the reamed acetabulum.The 58mm trident cluster psl shell was then implanted.

Manufacturer Narrative

An event regarding thread damage involving a trident acetabular window trial 58mm was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection confirms the reported thread damage.Significant damage was noted on the body of the device.Examination with material analysis engineer indicated that the threads stripped on trial.Damage observed consistent with contact against a hard object medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: there have been no other events for this lot.Conclusions: visual inspection shows significant damage on the device.Examination of the returned device in consultation with material analysis engineer indicated that the threads stripped on trial.Damage observed consistent with contact against a hard object.No further investigation for this event is possible at this time.If additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

Trident window trial 58mm disassembled from the trial/cup inserter handle during acetabular preparation.The acetabulum was reamed to 58mm prior to trailing the 58mm window trial.The window trial treads were stripped so a bone tamp was used to mobilize the window trial and disengage it from the reamed acetabulum.The 58mm trident cluster psl shell was then implanted.

• Brand Name: TRIDENT ACET WINDOW TRIAL 58MM
• Type of Device: HIP TRIAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6594850
• MDR Text Key: 76237109
• Report Number: 0002249697-2017-01691
• Device Sequence Number: 1
• Product Code: JDI
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2208-2058
• Device Lot Number: 28848201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR