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-513
Medical Device Problem Codes	Material Discolored (1170); Material Erosion (1214); Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.Device not returned.
Event or Problem Description
Knee revision due to instability.
Event or Problem Description
Knee revision due to instability.
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: visual inspection of the returned device indicated that the device is worn in the area where the condyles articulate, near the posterior edge as well as up against the raised middle portion.The device is discolored yellow and brown along the worn area.Material analysis: a material analysis was performed and concluded the following: "significant material removal occurred on both the lateral and medial sides of the insert due to wear due to normal contact with the femoral component.This wear was noticeably uneven and were surrounded by discoloration.Overload fractures occurred over much of the proximal surface consistent with a thinning of the cross section.No material non-conformances with the uhmwpe insert were found, nor any manufacturing defects seen on any of the device¿s surfaces which were investigated here." clinician review: a review of the provided medical information by a clinical consultant indicated: "the event description from the product inquiries summary states: knee revised due to instability.The revision operative report does not describe in detail the exact indication for the revision.The x-rays show from (b)(6) 2021 show a cemented tka without evidence of loosening.The patella has not been resurfaced.There is evidence of lateral tracking and wear of the lateral facet of the [patient's native] patella.The exact indication and root cause for this revision surgery and the root cause for this surgery cannot be determined from this limited documentation." 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 condyles articulate, near the posterior edge as well as up against the raised middle portion.The device is discolored yellow and brown along the worn area.A material analysis was performed and concluded the following: "significant material removal occurred on both the lateral and medial sides of the insert due to wear due to normal contact with the femoral component.This wear was noticeably uneven and were surrounded by discoloration.Overload fractures occurred over much of the proximal surface consistent with a thinning of the cross section.No material non-conformances with the uhmwpe insert were found, nor any manufacturing defects seen on any of the device¿s surfaces which were investigated here." a review of the provided medical information by a clinical consultant indicated: "the event description from the product inquiries summary states: knee revised due to instability.The revision operative report does not describe in detail the exact indication for the revision.The x-rays show from (b)(6) 2021 show a cemented tka without evidence of loosening.The patella has not been resurfaced.There is evidence of lateral tracking and wear of the lateral facet of the [patient's native] patella.The exact indication and root cause for this revision surgery and the root cause for this surgery cannot be determined from this limited documentation." 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
• 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: 12832382
• Report Number: 0002249697-2021-01925
• Device Sequence Number: 4364915
• Product Code: MBH
• UDI-Device Identifier: 07613327050554
• UDI-Public: 07613327050554
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 03/31/2014
• Device Model Number: 5530-G-513
• Device Catalogue Number: 5530-G-513
• Device Lot Number: MHDJNP
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2009
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 72 KG