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 Codes	Material Erosion (1214); Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/12/2021
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.
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 femoral condyles articulate.The posterior edge is significantly damaged and appears to have fractured.The locking mechanism is also fractured; this area of damage is consistent with the explantation attempt.The device is discolored yellow around the areas of wear/fracture.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.The surface on the side with more wear suffered a fracture when the cross section became too thin to support the applied stress.No material non-conformances with the uhmwpe insert were found, nor any manufacturing defects seen on any of the device¿s surfaces, all of which were investigated here." clinician review: a review of the provided medical information by a clinical consultant indicated: "the post-operative x-rays show a pressfit tka without evidence of mechanical mal-alignment or loosening.The pre revision x-rays show complete loss of medial joint space consistent with advanced wear of the polyethylene insert.The lack of medial polyethylene material thickness would lead to severe medial collateral ligament laxity and instability.Revision surgery for tka instability is confirmed.The indication for the revision was noted to be instability.Cause for the instability is marked wear of the medial aspect of the polyethylene insert leading to mcl laxity.The root cause for such significant wear at a relatively early postoperative 9 year follow up can not be determined with this limited information." 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 posterior edge is significantly damaged and appears to have fractured.The locking mechanism is also fractured; this area of damage is consistent with the explantation attempt.The device is discolored yellow around the areas of wear/fracture.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.The surface on the side with more wear suffered a fracture when the cross section became too thin to support the applied stress.No material non-conformances with the uhmwpe insert were found, nor any manufacturing defects seen on any of the device¿s surfaces, all of which were investigated here." a review of the provided medical information by a clinical consultant indicated: "the post-operative x-rays show a pressfit tka without evidence of mechanical mal-alignment or loosening.The pre revision x-rays show complete loss of medial joint space consistent with advanced wear of the polyethylene insert.The lack of medial polyethylene material thickness would lead to severe medial collateral ligament laxity and instability.Revision surgery for tka instability is confirmed.The indication for the revision was noted to be instability.Cause for the instability is marked wear of the medial aspect of the polyethylene insert leading to mcl laxity.The root cause for such significant wear at a relatively early postoperative 9 year follow up can not be determined with this limited information." 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
Knee revision due to instability.

• 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: 12832386
• Report Number: 0002249697-2021-01924
• Device Sequence Number: 4364918
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• 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: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 10/31/2016
• Device Model Number: 5530-G-411
• Device Catalogue Number: 5530-G-411
• Device Lot Number: MKPRYD
• 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: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2011
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG