MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV WITH GENTAMICIN US 1 PACK; BONE CEMENT

Model Number 6195-1-001

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Inadequate Osseointegration (2646); Joint Laxity (4526)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

Stryker orthopaedics is a distributor of this device, which is manufactured by osartis.The manufacturer has responsibility for regulatory decisions and mdr/mdv reporting.Supplier has been notified.Serious injury reports for hv products are also filed to the fda via stryker personnel.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.Not returned to the manufacturer.

Event Description

It was reported by the patient's attorney through a legal claim that allegedly on (b)(6) 2016 the patient underwent a right total knee arthroplasty with simplex hv bone cement.It is further alleged that on (b)(6) 2017 the patient underwent revision surgery due to alleged loosening.

Event Description

It was reported by the patient's attorney through a legal claim that allegedly on (b)(6) 2016 the patient underwent a right total knee arthroplasty with simplex hv bone cement.It is further alleged that on (b)(6) 2017 the patient underwent revision surgery due to alleged loosening.

Manufacturer Narrative

Reported event: an event regarding loosening involving a simplex cement mix was reported.Conclusions: the reported device is an oem product.Oem supplier investigation results ref # (b)(4).Immediate action: control of batch documentation.Root cause: patient-specific cause, final risk assessment: in order to rule out a product defect, the batch documentation was checked.During testing, no deviations were found, so that a product-specific cause can be excluded.Based on clinical data from published literature, aseptic loosening is a known common complication associated with joint replacement with or without bone cement, which have a variety of causes, e.G.The surgical method or patient behavior.Since it is not known whether the surgical techniques recommended in the ifu were used, no statement can be made as to whether this an influence on loosening of the joint.For this reason, no further actions will be done.Corrective action/preventive action: no action is required by stryker at this time as the investigation for this event is performed by the oem.H3 other text: device not available.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 10807832
• MDR Text Key: 215308011
• Report Number: 0002249697-2020-02364
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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 Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-001
• Device Lot Number: 615BA854DX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: No
• 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; Other
• Patient Age: 55 YR
• Patient Sex: Female