MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ACET WINDOW TRIAL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2208-2056A

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Trident cup trial was difficult to re-thread impactor into making it difficult to remove from patient.Surgeon had to use other means to get out.Surgeon used a bone hook and hammer to remove the trident cup.This was a right hip.

Manufacturer Narrative

An event regarding damaged threads of a trident modified window trial was reported.The event was confirmed.Method & results: device evaluation and results: the device color appears faded and is scratched.The threads on the device were notably damaged and worn.Significant damage was noted on the body of the device, consistent with extraction damage.Examination of the returned device with material analysis engineer noted the damage observed on threads is consistent with cross-threading and off axis loading medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar previous reported events.The reported thread damage was confirmed.Examination of the returned device with material analysis engineer noted the damage observed on threads is consistent with cross-threading and off axis loading.

Event Description

Trident cup trial was difficult to re-thread impactor into making it difficult to remove from patient.Surgeon had to use other means to get out.Surgeon used a bone hook and hammer to remove the trident cup.This was a right hip.

• Brand Name: TRIDENT ACET WINDOW TRIAL 56MM
• 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; 200 suhong road, sip; mahwah NJ 07430
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6151122
• MDR Text Key: 62146326
• Report Number: 0002249697-2016-03833
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

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: 2208-2056A
• Device Lot Number: MHK1MJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2009
• 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: 71 YR
• Patient Weight: 123