MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK 5CC HYDROSET INJECTABLE CEMENT; IMPLANT

Catalog Number 79-43905

Device Problems Crack (1135); Positioning Problem (3009)

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

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Please note, actual quantity of devices reported is two.Discarded at facility.

Event Description

It was reported by the company representative that during the procedure, the physician stated that the product was cracking when placed in patient.The procedure was completed sucessfully.On (b)(6) 2017 the physician had to re-visit the same patient and noticied that the product was not in place.Another hydroset was then utilized, and the physician reported that it was cracking again when placing in the patient.This procedure was completed succesfully as well.The sales rep was not present during these procedures.

• Brand Name: 5CC HYDROSET INJECTABLE CEMENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 7160142
• MDR Text Key: 96329829
• Report Number: 0008010177-2018-00002
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 79-43905
• Device Lot Number: V85SGIC02484
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention