MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5520B500
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	11/14/2018
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: not performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other events were reported for the lot indicated.Conclusions: the event could not be confirmed, nor the root cause determined because insufficient information was provided.Further information is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
It was reported that patient's right knee was revised due to loose patellar and tibial components (no possible cause or contributor for loosening were reported to or observed by rep).A triathlon size 5 cemented fixed baseplate, insert and all poly size 38 patella were revised to a triathlon baseplate, insert and stryker patella.Rep could not verify if cement used in primary was stryker.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #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: 8157432
• Report Number: 0002249697-2018-04015
• Device Sequence Number: 1732719
• Product Code: MBH
• UDI-Device Identifier: 07613327041057
• UDI-Public: 07613327041057
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: 06/30/2018
• Device Catalogue Number: 5520B500
• Device Lot Number: EDN7X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/12/2018
• 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: 75 YR
• Patient Weight: 122