MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SIMPLEX HV; BONE CEMENT

Catalog Number UNK_LIM

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2019

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

This pi is for simplex hv with no antibiotics from journal of arthroplasty 35 (220) s182-s189.In the journal of arthroplasty article "primary total knee arthroplasty performed using high-viscosity cement is associated with higher odds of revision for aseptic loosening," one table provides information that for simplex hv, with and without antibiotics, 20 revisions were performed for aseptic loosening.Study cohort (3718 patients total, including patients with competitor cement) had a mean age of 68.0 ±9.0 years.35.4% of patients were male, 64.6% female.

• Brand Name: UNKNOWN SIMPLEX HV
• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10527289
• MDR Text Key: 206768713
• Report Number: 0002249697-2020-01852
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/18/2020
• Initial Date FDA Received: 09/14/2020
• 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): Hospitalization; Required Intervention