MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +0MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 6942-7-065

Device Problems Device Slipped (1584); Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that surgeon was doing a right hemi arthroplasty and the unipolar taper head did not lock on the stem.Surgeon switched to a 28mm c-taper head and the c-taper head fit correctly.

Manufacturer Narrative

An event regarding a seating/locking issue involving a unitrax sleeve was reported.The event was not confirmed.Method & results: device evaluation and results: the returned device was unremarkable.A functional test confirmed that the impacted head on to the sleeve that was assembled on the stem; it locked and could not be removed.Medical records received and evaluation: a medical review was not performed because insufficient information was provided.No adverse consequences to the patient were reported.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed or duplicated as device locked as specified on the surgical protocol.

Event Description

It was reported that surgeon was doing a right hemi arthroplasty and the unipolar taper head did not lock on the stem.Surgeon switched to a 28mm c-taper head and the c-taper head fit correctly.

• Brand Name: UNITRAX C-TAPER SLEEVE +0MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5233572
• MDR Text Key: 31713312
• Report Number: 0002249697-2015-03877
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 6942-7-065
• Device Lot Number: 52816102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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: 84 YR