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

Catalog Number 6195-1-001

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding loosening involving simplex hv cement was reported.The event relates to product supplied by an oem.Method & results: device evaluation and results: not performed as the associated device is oem product.Medical records received and evaluation: not performed as the associated device is oem product.Device history review: not performed as the associated device is oem product.Complaint history review: not performed as the associated device is oem product.Conclusions: the reported device is an oem product investigated by aap.Confirmation that an aap investigation has been initiated by the oem supplier site was received, and has been attached within the communication log.The following devices were also listed in this report: simplex hv with gentamicin us 1 pack; cat#6195-1-001; lot#728ba877dy.It cannot be determined which, if either of these oem devices may have caused or contributed to the patient's experience.Oem product.

Event Description

It was reported that patient's right hip was revised as the acetabular component was pulling out of the patient's acetabulum due to the cement mantle not interdigitating with the patient's native bone.Surgeon reported that there are no allegations against any stryker devices, but that patient factors (reported as "sick and unhealthy") were the cause.A trident all poly constrained acetabular insert (cemented) and a 32 +7.5 c-taper lfit head were revised to an ras cup with an adm/mdm liner construct (revision head not reported).Update 06 dec 2018: trident shell catalog # 542-11-50e, lot#lynmee was implanted on (b)(6) 2008.The shell was explanted on (b)(6) 2018.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) 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
• Manufacturer Contact: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8174398
• MDR Text Key: 130671609
• Report Number: 0002249697-2018-04075
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

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: 6195-1-001
• Device Lot Number: 727BA870DY (OEM)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/18/2018
• 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
• Patient Age: 82 YR
• Patient Weight: 87