MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-409
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Laxity (4526)
Date of Event	08/13/2013
Type of Reportable Event	Serious Injury
Additional 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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "laxity to right total knee.".
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was confirmed via clinician review.Method & results: -device evaluation and results: not performed as product 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.-device history review: all 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 reported lot.Conclusion: it was reported that the patient's right knee was revised whereby the 9mm insert was revised with a 11mm one.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
It was reported through the communication of an attorney that allegedly the patient was revised due to "laxity to right total knee." *update on (b)(6) 2021: this pi is for revision surgery in 2013."[.] on (b)(6) 2013 with a preoperative diagnosis of laxity to right total knee.The procedure was a revision of the polyethylene insert.Surgeon removed the 9 mm insert and put in an 11 mm.".

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 8568697
• Report Number: 0002249697-2019-01795
• Device Sequence Number: 2191935
• Product Code: MBH
• UDI-Device Identifier: 07613327050479
• UDI-Public: 07613327050479
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 06/30/2012
• Device Model Number: 5530-G-409
• Device Catalogue Number: 5530-G-409
• Device Lot Number: TK8MKD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 09/28/2021
• 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: 44 YR