MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520-B-600

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 12/18/2014

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: x3 triathlon cs insert #6 11mm; cat# 5531-g-611; lot# ldr281, triathlon cr fem comp #6 r-cem; cat# 5510f602; lot# ekpyh.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported that, "my father has been implanted with triathlon prosthesis.Nowadays he has a lot of pain in the tibial part of the prosthesis.In some occasions he has been told that he may have an infection.He is worse than before the procedure.Since the beginning in (b)(6) 2014 he has had pain.He is (b)(6), corpulent and very heavy.The surgeon that implanted him believes that the tibial zone has to be reinforced with a kind of stronger anchorage.".

Manufacturer Narrative

An event regarding pain involving a triathlon baseplate was reported.The event was not confirmed.Device history review: the device was 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 regarding pain could not be determined from on the information provided.Pain can occur post-operatively for a number of reasons but it is a symptom rather than the cause of the issue the patient is experiencing.The reported devices remain implanted.Further information such as x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.It is noted that the event description states a number of questions regarding future actions for the patient, "what can be done?, what are the solutions?, should it need to be replaced?¿, to which only a healthcare provider can answer.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.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

It was reported that, "my father has been implanted with triathlon prosthesis.Nowadays he has a lot of pain in the tibial part of the prosthesis.In some occasions he has been told that he may have an infection.He is worse than before the procedure.Since the beginning in (b)(6) 2014 he has had pain.He is (b)(6) years old, corpulent and very heavy.The surgeon that implanted him believes that the tibial zone has to be reinforced with a kind of stronger anchorage.".

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5467609
• MDR Text Key: 39275262
• Report Number: 0002249697-2016-00612
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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: 02/03/2016

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: 03/31/2019
• Device Catalogue Number: 5520-B-600
• Device Lot Number: EHYMD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2014
• 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: 69 YR
• Patient Weight: 106