MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM PATELLA-ASYMMETRIC; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5552-L-299

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Swelling/ Edema (4577)

Event Date 02/21/2018

Event Type  Injury  

Event Description

Patient reported she had a left tka on (b)(6) 2018.Patient stated that since her surgery she has experienced swelling and pain.Patient had x-rays done and was told by her surgeon that her knee was loose and she requires revision surgery.

Manufacturer Narrative

Reported event: an event regarding loosening involving a triathlon patella was reported.The event was not confirmed.Method & results:  device evaluation and results: not performed as product remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: this inquiry reports a complaint of a patient who is over 3 years following total knee arthroplasty.She complains of pain and swelling and she states she has been told the implant is loose and requires revision surgery.I cannot confirm that this event (loosening) took place since i was not able to view any documentation for this except a radiology report of demineralization more prominent at 4 weeks postoperative.There is no clinical evidence provided to substantiate the report.Regarding the possible root cause of this event, there is no evidence that loosening occurred so i cannot opine on a root cause.As far as my knowledge of the implant, there has been no recall of any of the components.Stryker would have to confirm this.Device history review: could not be performed as lot code information was not provided.  complaint history review: could not be performed as lot code information was not provided.  conclusion: the event could not be confirmed as insufficient information was provided.Further information primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRITANIUM PATELLA-ASYMMETRIC
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13382022
• MDR Text Key: 285625714
• Report Number: 0002249697-2022-00133
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327013535
• UDI-Public: 07613327013535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2022

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 Model Number: 5552-L-299
• Device Catalogue Number: 5552-L-299
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 99 KG