MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK 10CC HYDROSET INJECTABLE CEMENT; IMPLANT

Catalog Number 79-43910

Device Problem Crack (1135)

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

Event Date 06/24/2014

Event Type  malfunction  

Event Description

(b)(4).Was used for a procedure and while the doctor was suturing (after the product had hardened), it cracked.

Manufacturer Narrative

Device not returned for evaluation as it is still implanted in patient.If additional information is received it will be reported on a supplemental report.Device is still implanted.

• Brand Name: 10CC 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: jamshed badarpura ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 3928990
• MDR Text Key: 4600130
• Report Number: 0008010177-2014-00170
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 79-43910
• Device Lot Number: ICO1712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2014
• 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