MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCK TIBIAL BASEPLATE-LM/RL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180603

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Discomfort (2330); Inadequate Osseointegration (2646)

Event Date 02/17/2012

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Dx tibial loosening, l uka, possible occult infection.Positive bone scan, slight elevation of white cell count in joint aspirate.Revision of left tka.

Manufacturer Narrative

An event regarding loosening involving a mako baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated, "no x-rays or bone scan reports or images are available for review.There is no examination of the explanted uka components.There is no confirmation, radiographically or in the revision operative report, of ¿aseptic loosening¿ of the left uka components.There is no evidence that factors relating to the primary unicompartment knee arthroplasty components¿ design, manufacturing or materials were responsible for this clinical situation".Device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot and referenced.Conclusions: the event could not be confirmed nor the root cause determined as sufficient information was not provided.A review of the provided medical records by a consulting clinician indicated that there is no confirmation, radiographically or in the revision operative report, of ¿aseptic loosening¿ of the left uka components.Additional information like x-rays or bone scan reports or images, clinical history, and results of bloodwork for infection are required to investigate the event further.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information and/or devices become available, this investigation will be reopened.

Event Description

Dx tibial loosening, l uka, possible occult infection.Positive bone scan, slight elevation of white cell count in joint aspirate.Revision of left tka.

• Brand Name: MCK TIBIAL BASEPLATE-LM/RL-SZ 3
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6437344
• MDR Text Key: 70969991
• Report Number: 3005985723-2017-00145
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2015
• Device Catalogue Number: 180603
• Device Lot Number: 26110410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2010
• 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): Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 90