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

Model Number	5551-G-299
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/23/2021
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
The customer reported that he revised a triathlon for instability and opened the knee to discover that the poly insert had broken which has caused the instability.The patient had a fall in (b)(6) 2020.The surgeon also reported that the patella had a wear pattern which the surgeon believes is not related to the implant being broken.The tkr was initially done on (b)(6) 2010.
Additional Manufacturer Narrative
An event regarding wear and instability involving a triathlon patella was reported.Wear was confirmed via evaluation of the returned device.Instability was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis and indicated the following: "inspection shows the articulating surface of the x3 triathlon insert with fracture.Damage consistent with delamination and material loss due to articulation against the femoral component was observed on the posterior portion of the medial condyle.Yellow discoloration consistent with oxidation, possibly a result of synovial fluid absorption, was observed on the insert.Also seen is the patella with material loss and yellow discolouration observed." material analysis: a material analysis was performed which concluded the following: "review of x3 triathlon cs insert #2 13mm, catalogue#: 5531-g-213, lot code lbp333 confirmed a fracture in posterior articulating surface edge of the medial condyle.Review of triathlon asymmetric x3 patella, catalogue#: 5551-g-299, lot code e015 confirmed material loss on the anterior and posterior surfaces.Characterisation using stereo microscopy confirmed damage on the posterior articulating surface edge of the medial condyle of the insert, consistent with delamination and material loss due to articulation against the femoral component.No manufacturing or material related defects were observed on the fracture surfaces examined." clinician review: a review of the provided medical information by a clinical consultant indicated: "materials reviewed: 03/23/2021: stryker pi report.Undated: operative report, primary right tka.Acl and pcl sacrificed (despite use of a cs knee) 3 degrees of slope in tibia.Good patellar tracking.Palacos cement with gent.Post op motion 0-1100, preop was 0-1150.Undated/unlabeled: implant sheet: triathlon cr femur #2, cs poly 13mm, a29 patella, #2 primary baseplate, cement gun and cement and cr preop kit.Undated: ap/lat right knee x-ray ¿post-primary¿, no gross abn.Undated: ap/lat right knee x-ray ¿pre-revision¿, femur slightly large rotation unclear on ap.The poly appears thinner than the post-primary film.Confirmation: the event cannot be confirmed without additional medical records.Root cause: the root cause cannot be confirmed without additional medical records and confirmation of the event." 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, wear/fracture of the insert, and wear of the patellar component.Visual inspection of the returned device was performed as part of the material analysis and indicated the following: "inspection shows the articulating surface of the x3 triathlon insert with fracture.Damage consistent with delamination and material loss due to articulation against the femoral component was observed on the posterior portion of the medial condyle.Yellow discoloration consistent with oxidation, possibly a result of synovial fluid absorption, was observed on the insert.Also seen is the patella with material loss and yellow discolouration observed." the material analysis concluded the following: "review of x3 triathlon cs insert #2 13mm, catalogue#: 5531-g-213, lot code lbp333 confirmed a fracture in posterior articulating surface edge of the medial condyle.Review of triathlon asymmetric x3 patella, catalogue#: 5551-g-299, lot code e015 confirmed material loss on the anterior and posterior surfaces.Characterisation using stereo microscopy confirmed damage on the posterior articulating surface edge of the medial condyle of the insert, consistent with delamination and material loss due to articulation against the femoral component.No manufacturing or material related defects were observed on the fracture surfaces examined." a review of the provided medical records by a clinical consultant indicated the following: "the poly appears thinner than the post-primary film.Confirmation: the event cannot be confirmed without additional medical records.Root cause: the root cause cannot be confirmed without additional medical records and confirmation of the event." it was reported that the patient suffered a fall prior to revision surgery; this trauma event may have contributed to the device 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.
Event or Problem Description
The customer reported that he revised a triathlon for instability and opened the knee to discover that the poly insert had broken which has caused the instability.The patient had a fall on (b)(6) 2020.The surgeon also reported that the patella had a wear pattern which the surgeon believes is not related to the implant being broken.The tkr was initially done on (b)(6) 2010.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11654690
• Report Number: 0002249697-2021-00675
• Device Sequence Number: 3497648
• Product Code: MBH
• UDI-Device Identifier: 07613327014792
• UDI-Public: 07613327014792
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 06/30/2015
• Device Model Number: 5551-G-299
• Device Catalogue Number: 5551-G-299
• Device Lot Number: E015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2010
• 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: 69 YR
• Patient Sex: Female