MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; BONE CEMENT

Catalog Number 6197-9-001

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/19/2013

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-350; lot# hwdh.Tri ts baseplate size 5; cat# 5521-b-500; lot# fiyz.Triathlon cr fem comp #5 l-cem; cat# 5510f501; lot# s388k.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Device not returned.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "failed right total knee.".

Manufacturer Narrative

Correction: lot code and catalog number updated.An event regarding revision involving a simplex cement was reported.The event was confirmed by the medical review.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "patient underwent a primary tka on (b)(6)2012.Post-operatively she developed reflex sympathetic dystrophy and had chronic pain and hypersensitivity about the knee.15 months later she underwent a revision tka where her femoral component was downsized and her tibial insert exchanged.The patient continued to have pain post revision.Review of these records confirm a revision tka for pain occurred.The patient was noted to have developed reflex sympathetic dystrophy following her index procedure.The root cause of the rsd and pain cannot be determined." -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that patient was revised due to failed right total knee.A review of the provided medical records and/or x-rays by a clinical consultant concluded that these records confirm a revision tka for pain occurred.The patient was noted to have developed reflex sympathetic dystrophy following her index procedure.The root cause of the rsd and pain cannot be determined.No further investigation is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to "failed right total knee.".

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8568441
• MDR Text Key: 143666835
• Report Number: 0002249697-2019-01781
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07613327045932
• UDI-Public: 07613327045932
• Combination Product (y/n): N
• PMA/PMN Number: K014199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

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 Expiration Date: 05/31/2017
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MET048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR