MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2101-0200

Device Problems Difficult to Insert (1316); Material Deformation (2976); Material Protrusion/Extrusion (2979)

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

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Our distributor reported that during a surgery the thread length was protruding past the dome of the acetabular trial and implant of 54 mm, and it was very difficult to implant.Seems that with other size of trial the problem did not occur.

Manufacturer Narrative

Additional information: returned to manufacturer on; pma/510(k)#; device evaluated by mfg.An event regarding assembly issue involving a trident impactor was reported.The event was confirmed.Dimensional inspection confirmed that the threaded stud protrusion past the impaction shoulder feature of the handle assembly was not within specification.The threaded stud should protrude.130, ±.005.The protrusion was measured and found to be out by +.0218, thereby indicating that it is out of specification.The dimension from the dowel pin to the shoulder of the handle should be.373 +/-.005 and was found to be out by -.021.Material analysis concluded, "plastic deformation was observed on the dowel pin consistent with an overload condition.The displacement observed between the dowel pin weld and shaft handle weld was approximately 749 m (0.0295 inches); and the displacement between the threaded stud and shaft handle were measured to be approximately 786 m (0.0309 inches).Based on the visual examination, a partial press-fit condition was achieved at the shaft/stud and stud/pin interfaces.Eds analysis of the pin, shaft, and stud all indicated a material consistent with 17-4 ph stainless steel.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.No other events were reported for the lot indicated.The reported event was confirmed as the returned instruments were assembled and found that the impactor protruded from the trial.The mar concluded that plastic deformation was observed on the dowel pin consistent with an overload condition.Although the dimensional report confirmed two dimensions were out of specification, the dimensional report and mar both noted that the pin and weld nugget were displaced similarly to the gap between the threaded stud and the shaft handle.This provides evidence that the device was manufactured and assembled correctly initially and that during use the pullout of the threaded stud from the hole occurred.Based on visual examination, a partial press fit condition was achieved between the shaft handle and threaded stud.No material or manufacturing defects were observed on the surfaces examined.

Event Description

Our distributor reported that during a surgery the thread length was protruding past the dome of the acetabular trial and implant of 54mm, and it was very difficult to implant.Seems that with other size of trial the problem did not occur.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6319405
• MDR Text Key: 67380541
• Report Number: 0002249697-2017-00516
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2101-0200
• Device Lot Number: 133212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2015
• 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