MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5521-B-200
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	06/22/2011
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.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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
Event or Problem Description
This pi was created based on the medical review provided for pi.The patient underwent revision surgery on (b)(6) 2011 due to tibial loosening whereby all triathlon ts components except the patella were revised to competitors products.
Event or Problem Description
This pi was created based on the medical review provided for pi.The patient underwent revision surgery on (b)(6) 2011.Due to tibial loosening whereby all triathlon ts components except the patella were revised to competitors products.
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon baseplate was reported and confirmed through a medical review for this patient.Method & results: -device evaluation and results: not performed as product was not returned -clinician review: a review of the provided medical records by a clinical consultant indicated: [.] after this fourth revision of (b)(6) 2010, subsequent failure occurred 1-year later requiring a fifth revision on (b)(6) 2011, with exchange of all triathlon components except x3 patella for competitor, rotating, platform revision, devices due to tibial.Loosening of the triathlon baseplate with additional stem extender and augments caused by bone stock loss and depressed bone biology after the previous infection history of the patient.Also this newly implanted competitor device of (b)(6) 2011 failed through tibial fixation failure requiring yet another sixth revision in oct 2013.Potential issues with component malposition or quality of cementation cannot be excluded until proof of contrary by x-ray information.Device history review: all 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant indicated: [.] revision devices due to tibial loosening of the triathlon baseplate with additional stem extender and augments caused by bone stock loss and depressed bone biology after the previous infection history of the patient.[.] potential issues with component malposition or quality of cementation cannot be excluded until proof of contrary by x-ray information.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRI TS BASEPLATE SIZE 2
• 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: 9495183
• Report Number: 0002249697-2019-04061
• Device Sequence Number: 1410418
• Product Code: MBH
• UDI-Device Identifier: 07613327026306
• UDI-Public: 07613327026306
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 10/31/2013
• Device Model Number: 5521-B-200
• Device Catalogue Number: 5521-B-200
• Device Lot Number: YSXP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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: 49 YR