MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH KX+ DURAT STAB INSERT MED 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6479-5-715
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
The patient was revised for instability and possible poly wear.
Additional Manufacturer Narrative
Lot code was initially entered in error and is actually unknown, therefore, expiration date, udi and manufacture date is also unknown.An event regarding joint instability involving a kinemax insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: not performed as no medical records were provided.Device history review: not performed as the lot details provided were invalid.Complaint history review: not performed as the lot details provided were invalid.Conclusions: the exact cause of the event could not be determined because further information such as product return, x-rays, operative reports, patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.
Event or Problem Description
The patient was revised for instability and possible poly wear.

• Brand Name: KX+ DURAT STAB INSERT MED 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6595855
• Report Number: 0002249697-2017-01697
• Device Sequence Number: 16344246
• Product Code: JWH
• UDI-Device Identifier: 07613327047264
• UDI-Public: (01)07613327047264(11)161130(17)211130(10)LFK739
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K921640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 6479-5-715
• Device Catalogue Number: 64795715
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR