MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5521-B-500
Medical Device Problem Codes	Loss of Osseointegration (2408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device not returned.
Event or Problem Description
It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra- operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.
Event or Problem Description
It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra- operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.
Additional Manufacturer Narrative
Additional information: update to explant date.An event regarding loosening and disassociation involving triathlon baseplate was reported.The reported loosening was not confirmed.The pre-op x-rays provided confirms the end cap disassociating from the baseplate.Method & results: device evaluation and results: the baseplate was returned for evaluation.Visual inspection indicated that on the inferior surface there is evidence of bone cement with bone in-growth on approximately half the baseplate.The end- cap was returned with it partially unscrewed from the baseplate.The device otherwise appears unremarkable for a device that was implanted since 2012.Clinician review: 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 and examination of explanted components.It was also stated that: the x-ray only confirms a disassociation at the junction of the stem and baseplate.It cannot determine it was due to a fracture or unscrewing - the last being the least likely possibility.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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRI TS BASEPLATE SIZE 5
• 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: 9566581
• Report Number: 0002249697-2020-00050
• Device Sequence Number: 2196765
• Product Code: MBH
• UDI-Device Identifier: 07613327026320
• UDI-Public: 07613327026320
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 01/31/2017
• Device Model Number: 5521-B-500
• Device Catalogue Number: 5521-B-500
• Device Lot Number: GMML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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: 56 YR
• Patient Weight: 113