MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S LFT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6481-1-110

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation involving mrh knee fem s lft was reported.The event was not confirmed. method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant. device history review: a review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other events for the lot referenced.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 and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that the patient's left knee was revised.As reported by rep: "stem loosening at the boss junction.(revised components) small mrh femur with 10mm augments medial lateral, 10x80 stem and modular components." spoke to rep.The stem was beginning to come unthreaded from the femoral components.There are no allegations against the revised augments or modular components.An mrh femoral component with stem, augments and blocks, tibial sleeve, insert, and tibial rotating component were implanted, and the patient's native patella was resurfaced.Rep provided usage sheets for primary and revision, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MRH KNEE FEM S LFT
• 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 ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11447726
• MDR Text Key: 238877050
• Report Number: 0002249697-2021-00408
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045130
• UDI-Public: 07613327045130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002552
• 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: 03/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 6481-1-110
• Device Catalogue Number: 64811110
• Device Lot Number: BYE9H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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: 48 YR