MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-402
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	12/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon femoral component was reported.The event was confirmed via clinician review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment: patient underwent primary right total knee arthroplasty in 2010 that failed in 2013 due to instability.Revision with polyethylene exchange was carried out.The patient underwent another revision in 2015 for recurrent instability.I can confirm that the event occurred since i was able to review the operation reports and i reviewed pre op and post op x-rays.Regarding the possible root cause of this event, i cannot determine this for certain.I don¿t see any abnormality with the implant itself.Instability is a well-known complication.Operative technique, soft tissue balancing, as well as activity level and body habitus are key in the longevity of a total knee replacement.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's knee was revised due to instability whereby the femoral component, baseplate and insert were revised.Clinician review indicated that the event was confirmed.No abnormality with the implant was noticed.Instability is a well-known complication.Operative technique, soft tissue balancing, as well as activity level and body habitus are key in the longevity of a total knee replacement.The exact cause of the event could not be determined.No further investigation is possible at this time.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
This pi is for revision surgery in 2015."in 2015 patient was seen again complaining of pain and instability in the right total knee replacement.On (b)(6) 2015 she underwent revision of the femoral and tibial components of her right total knee replacement.It is unclear why a revision of the components was performed.No mention was made of trying to correct the instability with another polyethylene exchange.The surgeon used components with a rotating platform revision tray with a femoral sleeve and adapter and the tibia had a metaphyseal sleeve.The patella was left in place.".

• Brand Name: TRIATHLON CR FEM COMP #4 R-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12506599
• Report Number: 0002249697-2021-01598
• Device Sequence Number: 20080234
• Product Code: MBH
• UDI-Device Identifier: 07613327040289
• UDI-Public: 07613327040289
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 5510-F-402
• Device Catalogue Number: 5510F402
• Device Lot Number: SSH6T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR