MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +0MM; IMPLANT

Catalog Number 6942-7-065

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

During an index surgery, the surgeon stated that the unitrax sleeve did not fit with the trunnion of the omnifit stem or it was an issue with the head.A new sleeve and head were opened and the surgery was completed successfully.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding assembly issues involving a unitrax sleeve and unitrax head was reported.The event was not confirmed.Method & results: -device evaluation and results: the head and the sleeve were returned assembled.Visual inspection noted marks of damage consistent with impaction during use.Dimensional inspection of the sleeve could not be performed as the device was assembled to the head.Functional testing confirmed that the sleeve will assemble with a c taper stem.-medical records received and evaluation: records were not provided for review.The devices were not implanted.-device history review: the device was manufactured and accepted into final stock with no discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined based on the information provided.During an index surgery, the surgeon stated that the unitrax sleeve did not fit with the trunnion of the omnifit stem or it was an issue with the head.The device details of the stem were not provided.The stem was left implanted and a new head and sleeve successfully implanted.The returned head and liner could not be dimensionally inspected as the devices were assembled together.A functional test of the sleeve confirmed that the device will assemble with a c taper stem.A review of the surgical protocol noted that after stem implantation, the modular adaptor sleeve is impacted onto the implanted stem with two or three mallet blows.The unitrax head component is then impacted onto the adaptor with two or three mallet blows.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available, this investigation will be reopened.

Event Description

During an index surgery, the surgeon stated that the unitrax sleeve did not fit with the trunnion of the omnifit stem or it was an issue with the head.A new sleeve and head were opened and the surgery was completed successfully.

• Brand Name: UNITRAX C-TAPER SLEEVE +0MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4621220
• MDR Text Key: 5760410
• Report Number: 0002249697-2015-00819
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

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 Expiration Date: 08/31/2019
• Device Catalogue Number: 6942-7-065
• Device Lot Number: 49060505
• Other Device ID Number: STER. LOT 1408MCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 03/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR