MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SIMPLEX HV WITHOUT 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 hv, with and without antibiotics, 4 revisions were performed for reasons other than 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.This pi is for simplex hv with no antibiotics.Journal of arthroplasty 35 (220) s182-s189.

• Brand Name: UNKNOWN SIMPLEX HV WITHOUT 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: 10515834
• MDR Text Key: 206374151
• Report Number: 0002249697-2020-01848
• 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