MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI RM/LL TIB AUG SZ3 10MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5546-A-302

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding tibial loosening involving a triathlon augment was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: not performed as medical records were not provided.Product history review: indicated all devices were manufactured and accepted into final stock with no reported 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.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.

Event Description

As reported: "patient's left tibial component was revised due to loosening¿all tibial components [12x50 stem, size 3 universal baseplate, two augments, 3x16 ts insert¿were explanted and revised to triathlon ts.Tibial side as a whole was loosened, no specific implant(s) cited".

• Brand Name: TRI RM/LL TIB AUG SZ3 10MM
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8265349
• MDR Text Key: 133706694
• Report Number: 0002249697-2019-00239
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327026474
• UDI-Public: 07613327026474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 5546-A-302
• Device Lot Number: N3K43A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR