MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 13MMX203MM FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64853313

Device Problem Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that the patient's right knee was revised due to a loose femoral stem.The entire construct except for the tibial baseplate and tibial stem were revised.Spoke to rep.Rep confirmed the only allegation was for the femoral stem.Rep provided primary and revision usage and explant pictures, and confirmed that no further information.

• Brand Name: MRS 13MMX203MM FEMORAL STEM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9070566
• MDR Text Key: 161585020
• Report Number: 0002249697-2019-03195
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327048452
• UDI-Public: 07613327048452
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 64853313
• Device Lot Number: 114449A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR