MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE6 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5526B600
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	10/24/2019
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.Device not returned.
Event or Problem Description
An uncemented triathlon baseplate was revised due to loosening.Swabs were taken during the procedure, with the results coming back ( over the phone) as no infection.Surgeon at the end of the case notes there was very little bony in growth on the tibia, though the femur was well fixed.He also noted a grey coloration of the tissues where the baseplate was not well fixed.
Additional Manufacturer Narrative
An event regarding revision due to loosening involving a triathlon baseplate was reported.The event was confirmed based on the clinician review.Method & results: device evaluation and results: visual inspection: visual inspection was performed on the returned device.It noted some minor scratches to the surface consistent with explant damage.Nothing else of note was seen.Dimensional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material evaluation was completed and indicated the following comments: ma: material analysis is not performed as loosening is not related to material integrity issue.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: rejected for medical review: x-ray images provided confirm tibial loosening, need additional information; primary and revision operative reports, clinical and past medical history and examination of explanted components.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 operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
An uncemented triathlon baseplate was revised due to loosening.Swabs were taken during the procedure, with the results coming back ( over the phone) as no infection.Surgeon at the end of the case notes there was very little bony in growth on the tibia, though the femur was well fixed.He also noted a grey coloration of the tissues where the baseplate was not well fixed.

• Brand Name: TRIATHLON PRIM BEAD PA SZE6 BP
• 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: 9353319
• Report Number: 0002249697-2019-03839
• Device Sequence Number: 11323429
• Product Code: MBH
• UDI-Device Identifier: 07613327041361
• UDI-Public: 07613327041361
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 01/17/2020

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: 09/30/2021
• Device Catalogue Number: 5526B600
• Device Lot Number: CH49R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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