MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G311

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Discharge (2225); Reaction (2414)

Event Date 03/23/2015

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

The patient stated that he has an infected left knee and suffers from pain.He claims there is a clear, brown and sticky discharge in the area since the primary surgery.He also states that his knee is swollen and has a knot/lump sticking out.His physical therapist reached out to his doctor and he was given levofloxacin.The patient stated that four surgeon¿s confirm that his knee is infected and that he should go back to the original surgeon for treatment.His primary surgeon states that there is nothing he can do for him and requested that he not return.He is able to walk and can bend the knee.He believes that his body is rejecting the knee and wants to know if the metal composition of his implants is contributing to his body¿s reaction.

Manufacturer Narrative

The following devices were also listed in this report: triathlon cr fem comp #3 l-cem; cat# 5510-f-301; lot# eckxn.Triathlon asymmetric x3 patella; cat# 5551-g-299; lot# 6lp4.Triathlon prim tib baseplate ¿ cemented; cat# 5520-b-300; lot# lapba.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mav003.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding infection and pain involving a triathlon insert was reported.The event was not confirmed.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "the primary harm involved is pain and difficulty with superficial wound healing best described as ¿stitch abscess¿.His incision was closed with staples and subcuticular absorbable suture.It is not uncommon to have punctate areas of superficial inflammation and drainage - ¿stitch abscess¿ - as the subcuticular sutures breakdown and reabsorb.No evidence for deep joint infection, inflammatory process or metal reaction was found." device history review: the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.The consulting clinician reviewed the provided medical records and found no evidence for deep joint infection, inflammatory process or metal reaction.Based on the information provided, the exact cause of the event could not be determined.A capa trend analysis was conducted for the reported failure mode and concluded pain is most likely a result from other factors not necessarily related to the device.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

The patient stated that he has an infected left knee and suffers from pain.He claims there is a clear, brown and sticky discharge in the area since the primary surgery.He also states that his knee is swollen and has a knot/lump sticking out.His physical therapist reached out to his doctor and he was given levofloxacin.The patient stated that four surgeon¿s confirm that his knee is infected and that he should go back to the original surgeon for treatment.His primary surgeon states that there is nothing he can do for him and requested that he not return.He is able to walk and can bend the knee.He believes that his body is rejecting the knee and wants to know if the metal composition of his implants is contributing to his body¿s reaction.

• Brand Name: X3 TRIATHLON CS INSERT #3 11MM
• 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 NJ NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6244476
• MDR Text Key: 64580153
• Report Number: 0002249697-2017-00200
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• 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: 5531G311
• Device Lot Number: LDZ739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• 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: 55 YR
• Patient Weight: 77