MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-600
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right knee was revised due to loosening of the tibial baseplate.Intra- operatively, surgeon reported dissatisfaction over the lack of contact of cement with the baseplate (reported as cement being in contact with the bone, but no cement interdigitating with the tibial baseplate).The patient's knee construct was revised (no allegations against the liner or femoral component were reported).
Additional Manufacturer Narrative
An event regarding tibial loosening involving a triathlon baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: the baseplate was returned for evaluation.Implantation and explantation damage was visible on the baseplate.Impression marks from contact with the insert were also visible on the baseplate.A review of the returned device by a material analysis engineer indicated: damage consistent with the implantation/explantation process was observed on the distal and proximal surface.The material was analyzed using x-ray fluorescence spectroscopy and is consistent with an astm f75 alloy.Impression markings were observed on the proximal surface of the baseplate, consistent with contact against the uhmwpe insert.No materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays.Product history review: indicated 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 lot referenced.Conclusion: a review of the returned device by a material analysis engineer indicated: damage consistent with the implantation/explantation process was observed on the distal and proximal surface.The material was analyzed using x-ray fluorescence spectroscopy and is consistent with an astm f75 alloy.Impression markings were observed on the proximal surface of the baseplate, consistent with contact against the uhmwpe insert.No materials or manufacturing discrepancies were observed on the surfaces examined.The event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history as well as additional serial dated x-rays are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right knee was revised due to loosening of the tibial baseplate.Intra- operatively, surgeon reported dissatisfaction over the lack of contact of cement with the baseplate (reported as cement being in contact with the bone, but no cement interdigitating with the tibial baseplate).The patient's knee construct was revised (no allegations against the liner or femoral component were reported).

• Brand Name: TRI TS BASEPLATE SIZE 6
• 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: 8912763
• Report Number: 0002249697-2019-02925
• Device Sequence Number: 11177201
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 07/30/2018
• Device Catalogue Number: 5521-B-600
• Device Lot Number: ILXP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/06/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: 84 YR