MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5536-B-400
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: the event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.  catalog numbers and lot codes of other devices listed in this report: 5531g409 x3 triathlon cs ins size 4 9mm ljk001.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
It was reported that the patient's left mako knee was revised due to pain.No possible cause or contributor for pain was reported.Intra-operatively, the tibial component was found to be a tiny bit loose, but the baseplate still required considerable effort to remove.A size 4 baseplate and 4x9 cs insert were revised to a size 4 universal baseplate with stem, and 4x16 cs insert.Rep provided primary and revision usage sheets and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRITANIUM BPLATE TRIATHLON S4
• 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: 11406023
• Report Number: 0002249697-2021-00371
• Device Sequence Number: 11608440
• Product Code: MBH
• UDI-Device Identifier: 07613327041491
• UDI-Public: 07613327041491
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: 09/18/2022
• Device Model Number: 5536-B-400
• Device Catalogue Number: 5536B400
• Device Lot Number: CTD18028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/03/2021
• 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: 51 YR