MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-613

Device Problems Malposition of Device (2616); No Apparent Adverse Event (3189)

Patient Problems Fall (1848); Pain (1994); Injury (2348)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation the following devices were also listed in this report: triathlon symmetric x3 patella; cat# 5550-g-339; lot# nwk6 triathlon fix.Peg 2 per pk; cat# 5575-x-000; lot# ekj7r triathlon ps fem component, cemented; cat# 5515-f-601; lot# jwxua triathlon prim tib baseplate - cemented; cat# 5520-b-600; lot# kjlea unknown device; cat# reported as 00-1112-140-01; lot# 77604366 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

His knee keeps giving out due to pain.Knee keeps popping out of place.He has fallen 20 times.A scheduled revision on monday (b)(6) 2016 due to pain.

Manufacturer Narrative

An event regarding loosening involving a triathlon insert was reported.Conclusion: there is no indication that the product reported in this investigation contributed to the event since patient was revised due to aseptic loosening of femoral and tibial components.No other allegations were made against the insert therefore it is considered as concomitant.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

His knee keeps giving out due to pain.Knee keeps popping out of place.He has fallen 20 times.A scheduled revision on monday (b)(6) 2016 due to pain.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6154617
• MDR Text Key: 61732192
• Report Number: 0002249697-2016-03859
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

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: 09/30/2019
• Device Catalogue Number: 5532-G-613
• Device Lot Number: MNMPR1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2014
• 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): Other
• Patient Age: 44 YR
• Patient Weight: 132