MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NAV STRAIGHT CUP POSITIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2124-1200

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

It was reported that the cup inserter stripped the threads while surgeon was impacting trial cup.

Manufacturer Narrative

An event regarding thread damage of trail cup involving a navigation introducer was reported.The event was not confirmed.-device evaluation could not be performed as no items associated with the event were returned or made available for identification or evaluation.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Neither the event was confirmed nor the root cause could be determined because the device was not returned for evaluation and insufficient information was provided.If the device and/or additional information is received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that the cup inserter stripped the threads while surgeon was impacting trial cup.

Event Description

It was reported that the cup inserter stripped the threads while surgeon was impacting trial cup.

• Brand Name: NAV STRAIGHT CUP POSITIONER
• 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: 6146304
• MDR Text Key: 61720779
• Report Number: 0002249697-2016-03827
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

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: 2124-1200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided; 08/07/2017
• Supplement Dates FDA Received: 02/28/2017; 08/30/2017
• 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