MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5551-G-350

Device Problem Break (1069)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient required patella revision.A previously implanted triathlon patella was replaced with a new patella.Upon revision of patella, it was noticed two of the lugs were no longer present.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon patella was reported.The event was confirmed.Device evaluation and results: a material analysis has been performed.The report concluded: "the patella insert had two of its lugs fractured off.The fracture origins and directions of propagations for the two fractured lugs could not be determined due to post-fracture abrasion.Material damage was observed on the articulating surface, consistent with commonly-identified damage modes in uhmwpe inserts.No material or manufacturing defects were observed on the device features examined." medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "no description of the patellar tracking or patellar skyline x-rays to identify subluxation or malposition as contributory to the eventual fatigue fracture of the fixation lugs in this case are available.There is no evidence of manufacturing or material defects contributing to this clinical situation.No brand of cement utilized in this case was identified." device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no other similar events for the reported lot.Conclusions: a material analysis and clinical review confirmed the event however, the exact cause of the event could not be determined because insufficient information was provided.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient required patella revision.A previously implanted triathlon patella was replaced with a new patella.Upon revision of patella, it was noticed two of the lugs were no longer present.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6813285
• MDR Text Key: 83425731
• Report Number: 0002249697-2017-02587
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Catalogue Number: 5551-G-350
• Device Lot Number: P218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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: 73 YR
• Patient Weight: 91