MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SIMPLEX BONE CEMENT

Catalog Number UNK_LIM

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Inconsistency in simplex bone cement setting time leading to complications with surgery.Complaint has unspecified cases and details.Update (b)(6) 2020: the customer has reported that it is not related to any specific event or lot.The hospital has noticed inconsistency in the cement setting times, a combination of slow and fast setting times, across all the cements.They are not able to provide specific details of cases, patients or specific products.They did not note any cases where the cement had to be revised though.Doctor does not feel there is an issue with the cement, rather that it is the climate and environment that is affected the cement setting times.The hospital has noted that during extreme temperatures in cairns, the hospitals air conditioning system struggles to regulate the temperature inside, which may be causing the inconsistency with the setting times.Doctor is undertaking the study to prove to the hospital that the climate of the region is affecting the setting times.

• Brand Name: UNKNOWN_SIMPLEX BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 10911413
• MDR Text Key: 228765997
• Report Number: 0002249697-2020-02552
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/26/2020
• 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): Other