MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SIMPLEX (NOT HV) WITH ANTIBIOTICS; BONE CEMENT, ANTIBIOTIC

Catalog Number UNK_LIM

Device Problem Loss of Osseointegration (2408)

Patient Problem Injury (2348)

Event Date 07/13/2019

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.

Event Description

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 (not hv, with and without antibiotics), 48 revisions were performed for aseptic loosening.Study cohort (687 patients total) had a mean age of 65.8 ±9.0 years.39.3% of patients were male, 60.7% female.This pi is for simplex with antibiotics.Journal of arthroplasty 35 (220) s182-s189.

• Brand Name: UNKNOWN SIMPLEX (NOT HV) WITH ANTIBIOTICS
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; IE NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 10515898
• MDR Text Key: 206374343
• Report Number: 0002249697-2020-01849
• Device Sequence Number: 1
• Product Code: MBB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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
• Date Manufacturer Received: 08/18/2020
• 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