MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-300
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/13/2018
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.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 patient's left knee was revised.As reported by rep: "aseptic loosening".A size 3 tibial baseplate and 13mm ps insert were revised.
Additional Manufacturer Narrative
An event regarding tibial loosening involving a triathlon ts baseplate component was reported.The event was confirmed during clinician review of the x-rays provided.Device evaluation and results: not performed as product was not returned a review of the provided medical records and x-rays by a clinical consultant confirms loss of cemented fixation of a tibial component in a ps tka occurred, however, the root cause cannot be determined as insufficient information was available.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.A review of the provided medical records and x-rays by a clinical consultant confirms loss of cemented fixation of a tibial component in a ps tka occurred however, the exact cause of the event could not be determined because insufficient information was provided.Additional information, including: operative reports, surgical implant records from the surgeries, dated pre and post op x-rays/imaging from the index and revision surgeries, outpatient office/clinic notes, implant retrieval are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that patient's left knee was revised.As reported by rep: "aseptic loosening".A size 3 tibial baseplate and 13mm ps insert were revised.

• Brand Name: TRI TS BASEPLATE SIZE 3
• 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: 7675870
• Report Number: 0002249697-2018-02126
• Device Sequence Number: 10974950
• Product Code: MBH
• UDI-Device Identifier: 07613327026313
• UDI-Public: 07613327026313
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/21/2018

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: 08/31/2017
• Device Catalogue Number: 5521-B-300
• Device Lot Number: HRIWA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/21/2018
• 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: 47 YR
• Patient Weight: 41