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

Catalog Number	5530-G-411
Medical Device Problem Codes	Material Distortion (2977); Scratched Material (3020); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision of triathlon insert.
Additional Manufacturer Narrative
Device returned to manufacturer on.An event regarding wear involving a triathlon insert was reported.The event was confirmed through visual inspection and material analysis.The mar concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The medical review indicated: suboptimal position of baseplate, femoral component or inadequate bearing thickness have contributed to instability with overload in the bearing causing abnormal bearing wear with baseplate loosening requiring revision.The exact anatomic failure problem cannot be determined due to lack of x-ray information.Indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the reported lot.The material analysis report (mar) concluded that: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The medical review indicated: suboptimal position of baseplate, femoral component or inadequate bearing thickness have contributed to instability with overload in the bearing causing abnormal bearing wear with baseplate loosening requiring revision.The exact anatomic failure problem cannot be determined due to lack of x-ray information.No further investigation for this event is possible at this time.
Event or Problem Description
Revision of triathlon insert.

• 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
• MDR Report Key: 6996275
• Report Number: 0002249697-2017-03180
• Device Sequence Number: 1851006
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2020
• Device Catalogue Number: 5530-G-411
• Device Lot Number: 318J65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 01/18/2018
• 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: 72 YR
• Patient Weight: 105