MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIBIAL B/PLT KEEL SML 1; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: 64786690ti- dur reg fluted stem12x155mm1 -t3649; 64952115-gmrs small axle1- ctd12004.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Rep was notified that there were explants ready to be picked up at the surgeon's request.The surgeon is not a stryker user and will release no further information.
Additional Manufacturer Narrative
An event regarding revision involving mrh baseplate was reported.The event was not confirmed.   method & results:  device evaluation and results: visual inspection: the device was returned and indicates newly explanted devices with biological matter on them but nothing remarkable to report.Ma - material analysis is not performed as this is not related to material integrity.Damage consistent with explantation.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Clinician review: no medical records were received for review with a clinical consultant   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:  the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.   the following devices were also listed in this report: catalog # 64786690ti- dur reg fluted stem12x155mm1 - lot # t3649.Catalog # 64952115-gmrs small axle1- lot # ctd12004.Cat # 64812100 - mrh tib rot comp xs-xl - lot # 109629.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Rep was notified that there were explants ready to be picked up at the surgeon's request.The surgeon is not a stryker user and will release no further information.

• Brand Name: MRH TIBIAL B/PLT KEEL SML 1
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11603058
• Report Number: 0002249697-2021-00596
• Device Sequence Number: 3621972
• Product Code: KRO
• UDI-Device Identifier: 07613327045307
• UDI-Public: 07613327045307
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: 02/28/2022
• Device Model Number: 6481-3-110
• Device Catalogue Number: 64813110
• Device Lot Number: BP74E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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