MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5537-G-516

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976); Scratched Material (3020)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been 2 other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that patient's right knee was revised due to dislocation.Rep reported that no ligament damage was reported.The post of the insert was not locked in to the box opening of the femoral component.

Event Description

It was reported that patient's right knee was revised due to dislocation.Rep reported that no ligament damage was reported.The post of the insert was not locked in to the box opening of the femoral component.Update: "the medial position of the revision tibial component and the distal position of the joint line in the revision total knee arthroplasty likely resulted in increased stress to the ts insert stability resulting in two dislocations and a later anterior implant subluxation." the consulting clinician clarified that this conclusion reflects an alignment issue of the tibial baseplate and femoral component leading toward subsequent subluxation and dislocation.

Manufacturer Narrative

Additional information provided: event, /gtin: an event regarding revision due to dislocation involving a triathlon ts insert component was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis was performed on the returned device which concluded: in-vivo service related damages to the articulating surface of the insert included scratching and third body indentations.These are commonly identified damage modes on uhmwpe inserts.The adhered debris is consistent with a co-cr-mo alloy.The revision stabilizing post was damaged at the distal end.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: clinician review of the medical records provided indicated "no examination of any explanted components except for the insert from the(b)(6)2018 revision surgery and no primary left total knee arthroplasty operative report or list of components are available for review.The medial position of the revision tibial component and the distal position of the joint line in the revision total knee arthroplasty likely resulted in increased stress to the ts insert stability resulting in two dislocations and a later anterior implant subluxation.There is no evidence that factors of implant design, manufacturing or materials were responsible for this clinical situation".-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusion: clinician review of the medical records provided indicated "no examination of any explanted components except for the insert from the (b)(6)2018 revision surgery and no primary left total knee arthroplasty operative report or list of components are available for review.The medial position of the revision tibial component and the distal position of the joint line in the revision total knee arthroplasty likely resulted in increased stress to the ts insert stability resulting in two dislocations and a later anterior implant subluxation.There is no evidence that factors of implant design, manufacturing or materials were responsible for this clinical situation".No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: NO 5. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM
• 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: 7529424
• MDR Text Key: 108743171
• Report Number: 0002249697-2018-01493
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

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: 11/30/2018
• Device Catalogue Number: 5537-G-516
• Device Lot Number: MMP1AX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 119