MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI CEMENTED STEM 12MMX50MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5560-S-112

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

An event regarding possible infection and instability involving a triathlon cemented stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: 2 other similar events were reported for the lot and sterile lot.Conclusions: it was reported that the patient was revised for instability and possible infection.The reported event cannot be confirmed or the exact cause of the event cannot be determined as insufficient information was provided.Additional information including operative reports, progress notes, x-rays, pathology reports 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 through the submission of a revision implant sheet that patient's right knee was revised.A note at the bottom of the sheet reports "revised for instability and possible infection".An mrh knee construct was revised to an mrh/ gmrs knee construct.

Manufacturer Narrative

Correction: update to implant and explant dates.An event regarding possible infection and instability involving a triathlon cemented stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: 2 other similar events were reported for the lot and sterile lot: pi 2284945 and pi 2285073 were for the same patient and device but different event.Conclusions: it was reported that the patient was revised for instability and possible infection.The reported event cannot be confirmed or the exact cause of the event cannot be determined as insufficient information was provided.Additional information including operative reports, progress notes, x-rays, pathology reports 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 through the submission of a revision implant sheet that patient's right knee was revised.A note at the bottom of the sheet reports "revised for instability and possible infection".An mrh knee construct was revised to an mrh/ gmrs knee construct.

• Brand Name: TRI CEMENTED STEM 12MMX50MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9648904
• MDR Text Key: 188648825
• Report Number: 0002249697-2020-00187
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327026528
• UDI-Public: 07613327026528
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 5560-S-112
• Device Catalogue Number: 5560-S-112
• Device Lot Number: 0066007H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 91