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

Catalog Number 2208-4053

Device Problems Break (1069); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The thread off the trident impactor handle and tritanium window trial stripped off both items during impaction of the trial window.

Manufacturer Narrative

An event regarding thread damage involving a titanium trial was reported.The event was confirmed.Method & results: device evaluation and results: although product was not returned but as per provided images the threads were found stripped off and the trial was having blood on it.Material, dimensional and functional analysis was not performed since the product was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: not performed since lot was not provided.Complaint history review: not performed since lot was not provided.Conclusions: it was reported that the threads of the trident impactor handle and titanium window trial stripped off of both items during impaction of the trial window.Although product was not returned but as per provided image the threads were found stripped off and the trial was having blood on it.No further investigation for this event is possible at this time since the device was not returned.If device is returned and additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The thread off the trident impactor handle and titanium window trial stripped off both items during impaction of the trial window.

• Brand Name: TRITANIUM ACETABULAR TRIAL
• 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 SUZHIOU; no. 18 wuxiang, epz zone a; 200 suhong road, sip; suzhou 21502 1; CN 215021
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7144939
• MDR Text Key: 95730630
• Report Number: 0002249697-2017-03673
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K161569
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2208-4053
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR