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 Remove (1528); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The company representative reported that the surgeon had an issue with a trident hemispherical shell and the trident impactor.The cup was impacted into the patient and the surgeon couldn't unscrew the cup from the impactor.This meant the cup had to be removed and a new cup opened and new impactor used.The surgeon couldn't remove the cup even when it was removed from the patient.The stryker sales rep was handed the impactor and shell after the case and did manage to unscrew them, but it was very tight as if it was cold welded.

Manufacturer Narrative

An event regarding disassembly issue involving a trident impactor was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: the device appears to be in used but good condition.Dimensional inspection: a dimensional inspection of the returned device found the device to be dimensionally compliant.Functional inspection: not performed as the shell from the reported event was not returned.The cutting edge impactor was found to be dimensionally complaint and there was no galling or damage of the threads.Material analysis: not performed as reported event is not related to material integrity.Medical records received and evaluation: not performed as medical records were not provided for review.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the event could not be confirmed.Further information such as return of trident shell associated with this event and/or surgical notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

The company representative reported that the surgeon had an issue with a trident hemispherical shell and the trident impactor.The cup was impacted into the patient and the surgeon couldn't unscrew the cup from the impactor.This meant the cup had to be removed and a new cup opened and new impactor used.The surgeon couldn't remove the cup even when it was removed from the patient.The stryker sales rep was handed the impactor and shell after the case and did manage to unscrew them, but it was very tight as if it was cold welded.

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6652037
• MDR Text Key: 78041022
• Report Number: 0002249697-2017-01928
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K161569
• 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: 05/29/2018

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: 2101-0200
• Device Lot Number: 140027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• 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