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-709

Device Problems Pitted (1460); Naturally Worn (2988)

Patient Problems Fall (1848); Unspecified Infection (1930); Skin Discoloration (2074); Injury (2348); Joint Swelling (2356)

Event Date 03/27/2015

Event Type  Injury  

Event Description

(b)(6) had total knee replacement done in (b)(6) of last year.He was getting along great and was very satisfied with his results.Roughly three weeks ago (b)(6) was on a hike and fell.After his fall his knee began to swell and get red.He thought this was due to the impact of his fall.This however was not the case as his leg continued to get worse.He came to dr.(b)(6) office and upon evaluation began getting worked up for infection.On monday evening dr.(b)(6) brought (b)(6) to the operating room and did an i&d with poly exchange in hopes to get rid of infection before having to do an explant.Dr.(b)(6) noticed some pitting and wear on the implant.I am sending the implant back for evaluation.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown ps poly insert.When completed, the investigation results will be submitted in a supplemental report.Not returned to the manufacturer.

Manufacturer Narrative

An event regarding infection involving an unknown insert was reported.The event was not confirmed.Method and results: 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: no medical records or x-rays were made available for evaluation.Device history review: not performed as the device was not properly identified.Complaint history review: not performed as the device was not properly identified.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Mr.(b)(6) had total knee replacement done in (b)(6) of last year.He was getting along great and was very satisfied with his results.Roughly three weeks ago mr.(b)(6) was on a hike and fell.After his fall his knee began to swell and get red.He thought this was due to the impact of his fall.This however was not the case as his leg continued to get worse.He came to dr.(b)(6) office and upon evaluation began getting worked up for infection.On monday evening dr.(b)(6) brought mr.(b)(6) to the or and did an i&d with poly exchange in hopes to get rid of infection before having to do an explant.Dr.(b)(6) noticed some pitting and wear on the implant.I am sending the implant back for evaluation.

Manufacturer Narrative

An event regarding infection involving a triathlon insert was reported.The event of infection was not confirmed however, the event of damage of the insert was confirmed by inspection of the returned device.Method & results: - device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 10-aug-2018 which indicated the articulating, distal, anterior and posterior surfaces of the insert are shown.The part was examined with the aid of a stereo microscope at magnifications up to 50x.Damage was observed on the condyles of the insert.Impressions markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Damage consistent with the explantation process was observed on the insert and locking wire.Detailed images of the condyles were observed.Burnishing, scratching and third-body indentations were observed on the condyles.These are common damage modes of uhmwpe.The posterior surface of the insert post with damage being observed.This damage is potentially due to contact against the femoral component.A material analysis has been performed.The report concluded: burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Impression markings, likely from contact with the baseplate, in addition to explantation damage were also observed on the insert.Additionally, damage on the post of the insert was observed.This is potentially due to contact against femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.- clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "reportedly patient underwent an i&d and tibial polyethylene liner exchange for presumed infection 6 months after implantation.Note was reportedly made by the surgeon of ¿pitting and wear¿ on the explanted liner.The explanted tibial insert was sent for material analysis.Visual analysis identified burnishing, scratching and third body identations on the articulating surfaces.These are common modes of uhmwpe damage.The event of infection following tka cannot be confirmed as insufficient information has been received for review.The event of pitting and wear of a tka polyethylene liner was be confirmed by material analysis.The findings were consistent with common modes of uhmwpe damage.- device history review: a review of the product history review indicated the devices were accepted into final stock with no reported discrepancies.- complaint history review: there has been no other event for the lot & sterile lot referenced.Conclusions: it was reported that the patient was getting worked up for infection.Also, it was noticed that the insert had some pitting and wear.Material analysis for the returned device noted that burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Impression markings, likely from contact with the baseplate, in addition to explantation damage were also observed on the insert.Additionally, damage on the post of the insert was observed.This is potentially due to contact against femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the available medical records by the consulting clinician noted that the event of infection following tka cannot be confirmed as insufficient information has been received for review.The event of pitting and wear of a tka polyethylene liner was be confirmed by material analysis.The findings were consistent with common modes of uhmwpe damage.No further investigation for this event is possible at this time as insufficient information was provided.Further information such as pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Mr.B.Had total knee replacement done in october of last year.He was getting along great and was very satisfied with his results.Roughly three weeks ago mr.B.Was on a hike and fell.After his fall his knee began to swell and get red.He thought this was due to the impact of his fall.This however was not the case as his leg continued to get worse.He came to dr.W's office and upon evaluation began getting worked up for infection.On monday evening dr.W.Brought mr.B.To the or and did an i&d with poly exchange in hopes to get rid of infection before having to do an explant.Dr.W.Noticed some pitting and wear on the implant.I am sending the implant back for evaluation.

• 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
• MDR Report Key: 4762778
• MDR Text Key: 15244613
• Report Number: 0002249697-2015-01482
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 5532-G-709
• Device Lot Number: LDN791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 94