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

Catalog Number 2101-0200

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Md could not reattach cup impactor.

Manufacturer Narrative

An event regarding assembly issue involving a 2101-0200 was reported.The event was not confirmed.Method and results: device evaluation and results: a functional test was conducted with universal impactor/positioner (cat 2101-0200 lot code smm9n00) and an acetabular shell (cat 500-11-58f lot code 40376301).The shell was able to be threaded onto the impactor/positioner as intended.There was no force or issues involved with the threading of the component onto the instrument.A discussion with the mar group, concluded based on a visual inspection with the aid of a microscope, found a little cross threading on the top of the device.Medical records received and evaluation: not performed as no medical records were returned.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.Conclusions: the exact cause of the event could not be determined since we could not replicate the issues with threading a shell onto the impactor/positioner.During the functional the shell was able to be threaded onto the impactor/positioner as intended.There was no force or issues involved with the threading of the component onto the instrument.The mar group concluded that through visual inspection there was a little cross threading found on the top of the device.This cross threading did not enable the shell to be threaded on the impactor/positioner.No material or manufacturing defects were observed on the surfaces examined.

Event Description

Md could not reattach cup impactor.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5867985
• MDR Text Key: 51823868
• Report Number: 0002249697-2016-02576
• 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: 06/17/2016

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: B6KFF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2011
• 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