MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI POST AUGMENT SZ5 5MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5543-A-500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event an event regarding loosening involving a triathlon augment was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: need operative reports, office/clinical reports, serial x- rays, etc.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 have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, operative reports, office/clinical reports, serial x-rays are 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 the patient's right knee was revised due to pain and loss of function.Intra- operatively, the following was noted: the size 5 cemented femoral component was loose; there was a fracture at the junction of the femoral stem and 12x100 stem; the cemented tibial component was loose; the junction of the stem extender and 12x50 stem on the tibial side was loose.The patient's entire ts knee construct (including five augments) was revised to a triathlon ts knee construct with a cone.Rep provided one page of the primary operative report, and reported that no further information will be released by the hospital or surgeon.

• Brand Name: TRI POST AUGMENT SZ5 5MM
• 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: 8981444
• Report Number: 0002249697-2019-03156
• Device Sequence Number: 10831902
• Product Code: MBH
• UDI-Device Identifier: 07613327014853
• UDI-Public: 07613327014853
• 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: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 12/03/2015
• Device Catalogue Number: 5543-A-500
• Device Lot Number: DSUK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/10/2019
• 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: 72 YR