MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 5551-G-350

Device Problems Unstable (1667); Delamination (2904); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

While revising the patients knee for instability upon exposure, surgeon noted what appears to be delamination on the patella, medial surface of the tibia and backside of the post.The implants were removed and replaced at that time without complication.

Manufacturer Narrative

An event regarding instability involving a triathlon patella was reported.The event was not confirmed.Device evaluation and results: visual inspection of returned device was done as a part of mar.Mar confirmed that in-vivo service-related damage to the articulating surfaces of the patella insert was delamination.This is commonly identified damage mode on uhmwpe patella inserts.There was no evidence of manufacturing or material defects on the returned ultra-high molecular weight polyethylene (uhmwpe) inserts.Medical records received and evaluation:not performed as no medical records were provided.Device history review: indicate all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review of the complaint history confirmed that there were no other similar reported events for the lot.Conclusions: on the basis of mar , the investigation concludes that delamination was observed on the surface of device with slight damages.These damages are in-vivo service-related damage to the articulating surfaces of the patella insert was delamination.This is commonly identified damage mode on uhmwpe patella inserts.There was no evidence of manufacturing or material defects on the returned ultra-high molecular weight polyethylene (uhmwpe) inserts.However, the exact cause of instability cannot be determined.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.

Event Description

While revising the patients knee for instability upon exposure, surgeon noted what appears to be delamination on the patella, medial surface of the tibia and backside of the post.The implants were removed and replaced at that time without complication.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6350722
• MDR Text Key: 68087792
• Report Number: 0002249697-2017-00629
• Device Sequence Number: 1
• Product Code: MBH
• 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,Followup
• Report Date: 04/20/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 5551-G-350
• Device Lot Number: 991R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2009
• 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: 67 YR
• Patient Weight: 103