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

Catalog Number 6195-1-001

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

Patient Problems Pain (1994); Injury (2348)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported through the filing of a lawsuit that allegedly on (b)(6) 2015 the patient underwent a right sided tka with simplex hv bone cement to cement all components.It is further alleged that the patient was revised on (b)(6) 2018 and operative notes show aseptic loosening of her knee components caused by the simplex hv bone cement and debonding of the tibial component.It is alleged that the surgeon noted in the revision operative report "tibial component was found to be grossly loose without evidence of cement to implant bonding.".

Event Description

It was reported through the filing of a lawsuit that allegedly on (b)(6) 2015 the patient underwent a right sided tka with simplex hv bone cement to cement all components.It is further alleged that the patient was revised on (b)(6) 2018 and operative notes show aseptic loosening of her knee components caused by the simplex hv bone cement and debonding of the tibial component.It is alleged that the surgeon noted in the revision operative report "tibial component was found to be grossly loose without evidence of cement to implant bonding.".

Manufacturer Narrative

Reported event an event regarding loosening involving a simplex cement mix 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.Written acknowledgement from the oem supplier that an investigation has been initiated at the oem supplier site was received, and has been attached within the communication log.Supplier issue ref #(b)(4).H3 other text : device not returned.

• 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
• MDR Report Key: 10072618
• MDR Text Key: 191535485
• Report Number: 0002249697-2020-00953
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

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: 6195-1-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention