MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 15MM X 127MM FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64853015

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device 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

Wrong size stem was implanted.Stem was then explanted and correct size put in.No change in outcome appeared to have happened".An 11 x 127 mrs straight cemented stem was implanted.Update 24/january/2019: spoke to rep.In order to remove the originally implanted stem, the patient's femur had to be split to explant the device.The cables were then implanted with the new stem.Rep reported a surgical delay of approximately 15 minutes.It is unknown if a tourniquet was in use at that time.

• Brand Name: MRS 15MM X 127MM 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8336956
• MDR Text Key: 136065132
• Report Number: 0002249697-2019-01038
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327049367
• UDI-Public: 07613327049367
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 64853015
• Device Lot Number: 171995B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2017
• 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: 86 YR