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

Catalog Number 6942-7-065

Device Problem Mechanical Problem (1384)

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

Event Date 04/23/2019

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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

C-taper sleeve would not stay engaged to the trunion.Update: "situation was resolved by opening another uht unipolar head and a standard c-taper sleeve" delay in surgery: 5-7 min.

Manufacturer Narrative

Reported event: an event regarding assembly issue involving a other hip sleeve was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: the device was returned assembled inside the unitrax femoral head.It would not be possible to disassemble these devices without causing damage.Implantation damage was observed on the sleeve inner taper, no materials or manufacturing defects were observed.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

C-taper sleeve would not stay engaged to the trunion.Update: "situation was resolved by opening another uht unipolar head and a standard c-taper sleeve." delay in surgery: 5-7 min.

• 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
• MDR Report Key: 8627581
• MDR Text Key: 145635020
• Report Number: 0002249697-2019-02019
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327013467
• UDI-Public: 07613327013467
• Combination Product (y/n): N
• PMA/PMN Number: K992570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 6942-7-065
• Device Lot Number: 69081105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR