MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX C-TAPER SLEEVE +5MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 6942-7-075

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Primary procedure, right hemi hip.The surgeon reported that the 44mm unitrax head with +5 sleeve would not lock onto the trunnion of the omnifit mfx stem.A 45mm unitrax head and +0 sleeve which were already waiting in the o.R.Were used and performed as expected.Surgery completed successfully with no delay.The rep is trying to retrieve the wasted devices from the hospital, and provided the usage sheet for the procedure.No further information will be available.

• Brand Name: UNITRAX C-TAPER SLEEVE +5MM
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9087739
• MDR Text Key: 163758457
• Report Number: 0002249697-2019-03278
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327013474
• UDI-Public: 07613327013474
• 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
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 6942-7-075
• Device Lot Number: 67206602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• 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: 86 YR