MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520-B-600
Medical Device Problem Codes	Mechanical Problem (1384); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Patient is enrolled in the control arm of (b)(6).The study coordinator sent an e-mail to notify us that the patient is scheduled for tibial revision on (b)(6) 2017.The patient was seen in clinic on (b)(6) 2016 and the pa noted pain and instability with radiographic evidence of tibial component loosening.
Additional Manufacturer Narrative
Additional information: returned to manufacturer on an event regarding loosening involving a triathlon baseplate was reported.The event was confirmed.-device evaluation and results: a visual inspection of the returned device noted biological fixation matter in the cement pocket of the baseplate.There are also some scratches on the superior surface of the baseplate, most likely from explantation.Examination of the returned device with material analysis engineer noted biological fixation on the baseplate.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: "the primary harm involved is mechanical loosening of a primary cemented tibial tka baseplate.No evidence was presented indicating defect in design or manufacturing of the implant." -device history review: all devices in the reported lot 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.Visual inspection of the returned baseplate noted biological fixation matter in the cement pocket of the baseplate along with some scratches on the superior surface of the baseplate.Review of the provided medical records and x-rays with a clinical consultant indicated that the primary harm involved is mechanical loosening of a primary cemented tibial tka baseplate.However, based on the information provided, the exact cause of the event could not be determined.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
Patient is enrolled in the (b)(6) study.The study coordinator sent an e-mail to notify us that the patient is scheduled for tibial revision on (b)(6) 2017.The patient was seen in clinic on (b)(6) 2016 and the pa noted pain and instability with radiographic evidence of tibial component loosening.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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: 6297677
• Report Number: 0002249697-2017-00430
• Device Sequence Number: 10881420
• Product Code: MBH
• UDI-Device Identifier: 07613327050349
• UDI-Public: (01)07613327050349(11)151029(17)201031(10)TSVTB
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

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: 10/31/2020
• Device Catalogue Number: 5520-B-600
• Device Lot Number: TSVTB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 04/25/2017
• 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: 59 YR
• Patient Weight: 109