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-411
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
Knee revision due to instability.
Event or Problem Description
Knee revision due to instability.
Additional Manufacturer Narrative
An event regarding instability involving a triathlon insert was reported.The event was confirmed through medical review.Method & results -product evaluation and results: visual inspection of the returned device noted the following: damage was observed on the distal and anterior surfaces of the insert which is consistent with the explantation process.Backside impressions on the distal surface of insert are consistent with contact against a tibial base plate.Damage was observed on the articulating surface of the insert which is consistent with contact against the femoral component.The damage present on the articulating surface is consistent with burnishing, scratching, delamination, and third body indentations material loss consistent with contact against the femoral component was observed on the posterior portion of the medial condyle.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: on (b)(6) 2019 revision left total knee arthroplasty was performed for ¿instability¿.A brief, translated operative note states, ¿¿ synovitis, also light metal synovitis ¿ changed plastic ¿ raises the plastic and tightens ¿ laxity/instability ¿ change insert to #4/13 x3 cs insert ¿¿.Uncomplicated surgery was described.X-rays dated (b)(6) 2019 are an ap, lateral and patellar view, which are unchanged on the femoral side, but the tibial components demonstrate medial joint space narrower than the lateral.Based upon the information available for review, no determination can be made regarding the indication for the left total knee arthroplasty revision surgery, and if the damaged tibial insert photographs represented this case or if explantation damage was present.It is important to note that although the medical review notes that explantation damage was not confirmed to be present on the returned device, the mar confirms "damage was observed on the distal and anterior surfaces of the insert which is consistent with the explantation process." -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Clinical or past medical history, description of symptoms or instability, and post-operative follow-up after either the primary or revision surgeries are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: 9689946
• Report Number: 0002249697-2020-00256
• Device Sequence Number: 3474856
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 04/30/2016
• Device Model Number: 5530-G-411
• Device Catalogue Number: 5530-G-411
• Device Lot Number: MKEMX5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: 64 YR
• Patient Weight: 70