MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MEDIUM KRH ALL POLY TIBIA 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	64852208
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Collapse (2416)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a krh tibial component was reported.The event could not be confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Clinician review: no medical records were made available for review with consulting clinician.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's left tibial component was revised due to medial tibial bone collapse.The event could not be confirmed nor the exact cause of the event be determined because insufficient information was provided.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
"patient's left tibial component was revised due to medial tibial bone collapse.[kinematic rotating hinge knee, mrh knee bumper insert, mrh tibial bearing component] were removed and an mrh tibia was implanted with a 155mm stem.All information available to me is included in this report.".

• Brand Name: MEDIUM KRH ALL POLY TIBIA 8MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8417343
• Report Number: 0002249697-2019-01310
• Device Sequence Number: 1303802
• Product Code: JWH
• UDI-Device Identifier: 07613327047523
• UDI-Public: 07613327047523
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K972863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 64852208
• Device Lot Number: LPTC314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/13/2019
• 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: 53 YR
• Patient Weight: 121