MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-311
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information become available, 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 relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
A dr has reported a knee revision where he needed to exchange the poly insert.The patient had a size #3/11mm cs insert currently in.Upon explant dr.Noticed the insert was damaged posteriorly on the medial side.Update: surgeon stated the patient was complaining of pain and instability which lead to the revision.
Event or Problem Description
A dr has reported a knee revision where he needed to exchange the poly insert.The patient had a size #3/11mm cs insert currently in.Upon explant dr.Noticed the insert was damaged posteriorly on the medial side.Update: surgeon stated the patient was complaining of pain and instability which lead to the revision.
Additional Manufacturer Narrative
Reported event: an event regarding wear, crack/fracture, and instability involving a triathlon insert was reported.The events were confirmed via evaluation of the returned device and a review of the provided medical records by a clinical consultant.Method & results: product evaluation and results: visual inspection: the damage present on the posterior portion of the condyle was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Clinician review: a review of the provided medical information by a clinical consultant indicated: "materials reviewed: 08/23/2021: stryker pi report.(b)(6) 2016: implant log sheet x2.Triathlon cr #4 right femur, a32 asymmetric patella, triathlon primary tibial baseplate #3, cs polyethylene #3 11mm.(b)(6) 2016: postoperative note.Right djd, tka, implants as noted, cemented with simplex w/ tobra.Routine knee procedure with no obvious complications.(b)(6) 2021: unlabeled copy of ap knees, bilateral sunrise, lateral right knee x-rays.Right knee with significant wear or fracture of the medial polyethylene (medial joint space very narrow compared to lateral).Lateral view with posterior subluxation with femur well posterior on tibia.(b)(6) 2017: unlabeled copy of ap knees, bilateral sunrise, lateral right knee x-rays.Reasonable alignment of ap knees with some patellar tilt on sunrise.No subluxation on the lateral view.Confirmation: the x-rays were unlabeled however it appears that during the interval period (b)(6) 2017 until (b)(6) 2021 there had been medial collapse of the joint space and posterior subluxation of the femur.A revision surgery cannot be confirmed without additional records.Root cause: the root cause of the joint alignment change was likely the result of polyethylene wear or failure, but this cannot be determined without additional medical records and perhaps examination of the explant if the revision were confirmed.".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 was revised due to instability.Visual inspection of the returned device indicated that the device is worn in the area where the femoral condyles articulate.The damage present on the posterior portion of the condyle was consistent with delamination and material loss.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.A review of the provided medical information by a clinical consultant indicated: "the x-rays were unlabeled however it appears that during the interval period (b)(6) 2017 until (b)(6) 2021 there had been medial collapse of the joint space and posterior subluxation of the femur.A revision surgery cannot be confirmed without additional records.Root cause: the root cause of the joint alignment change was likely the result of polyethylene wear or failure." 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: X3 TRIATHLON CS INSERT #3 11MM
• Common Device Name: 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12466420
• Report Number: 0002249697-2021-01558
• Device Sequence Number: 17099220
• Product Code: MBH
• UDI-Device Identifier: 07613327045734
• UDI-Public: 07613327045734
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2020
• Device Model Number: 5531-G-311
• Device Catalogue Number: 5531G311
• Device Lot Number: LEC523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female