MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ACET WINDOW TRIAL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2208-2058

Device Problems Peeled/Delaminated (1454); Sticking (1597); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

A 58mm trident window trial got stuck in acetabulum during the trialing process.Impactor handle also stripped out trial when trying to remove.Surgeon was able to loosen trial by using a bone punch and mallet.Trial was removed in one piece but has damage to it.

Manufacturer Narrative

An event regarding damage involving a trident trial was reported.The event was confirmed.Device evaluation and results: examination with material analysis engineer indicated the consistent with explantation damage.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.Visual inspection shows significant damage on the device.Examination of the returned device in consultation with material analysis engineer showed that damage was occurred during trial removal.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

A 58mm trident window trial got stuck in acetabulum during the trialing process.Impactor handle also stripped out trial when trying to remove.Surgeon was able to loosen trial by using a bone punch and mallet.Trial was removed in one piece but has damage to it.

• Brand Name: TRIDENT ACET WINDOW TRIAL 58MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5880188
• MDR Text Key: 53045450
• Report Number: 0002249697-2016-02635
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• 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: 29960701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR