MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5530-G-411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/19/2018
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 reported lot.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.
Event or Problem Description
It was reported that patient's right knee was revised after patient complained of hearing a loud snap or crack in his knee.Surgeon revised on suspicion of a fractured poly insert.Intra-operatively, the suspicion was confirmed and the insert was revised.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed through return of the fractured device.Method & results: device evaluation and results: material analysis carried out on the returned device concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The posterior end of the medial condyle had fractured in overload.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: review of the provided medical records by a clinician indicated: no clinical or past medical history, no operative reports, and no serial x-rays or lateral views are available for review.No determination of range of motion or stability of the right knee prior to the revision is noted.In this morbidly obese male patient, after more than six years in situ, failure of the posterior aspects of the tibial insert in fatigue suggests soft tissue imbalance resulting in overload failure.No material or manufacturing discrepancies were noted in the material analysis report.Device history review: indicates all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: material analysis carried out on the returned device concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The posterior end of the medial condyle had fractured in overload.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No clinical or past medical history, no operative reports, and no serial x-rays or lateral views are available for review.No determination of range of motion or stability of the right knee prior to the revision is noted.In this morbidly obese male patient, after more than six years in situ, failure of the posterior aspects of the tibial insert in fatigue suggests soft tissue imbalance resulting in overload failure.No material or manufacturing discrepancies were noted in the material analysis report.While the event was confirmed through the return of the device and material analysis could confirm no identifiable materials or manufacturing discrepancies, without clinical or past medical history, operative reports, and serial x-rays or lateral views the clinician could not confirm a root cause for this event.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's right knee was revised after patient complained of hearing a loud snap or crack in his knee.Surgeon revised on suspicion of a fractured poly insert.Intra-operatively, the suspicion was confirmed and the insert was revised.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7789290
• Report Number: 0002249697-2018-02557
• Device Sequence Number: 1188412
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 5530-G-411
• Device Lot Number: MLR9XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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: 54 YR
• Patient Weight: 159