MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 2 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5540-A-202

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

Is was reported by stryker sale rep that during the revision surgery, the augment (5540-a-202)(triathlon femoral distal augment-right)(lot no bds4d) was bulged out at triathlon ts femoral component left (5512-f-201)(lot no bii3r).Surgeon has requested to use size 1 femoral distal augment-right (5540-a-102)(lot no bir3b).Patient is undergoing revision surgery due to post infected knee.Patient was on cement spacer update: stryker sales confirmed that the revision surgery completed on (b)(6).Is the second revision surgery.The first revision surgery is using non-stryker implant ( cement spacer) and the date is unknown.Sales also do not have the information on the primary surgery ( eg: date).Update 2 : this pi is submitted for implant found out having issue during the surgery on (b)(6) 2021.The implant was found bulged out when sales rep was installing to the femoral component before surgeon implanting into patient body.

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

It was reported by stryker sale rep that during the revision surgery, the augment (5540-a-202) (triathlon femoral distal augment-right) (lot no bds4d) was bulged out at triathlon ts femoral component left (5512-f-201) (lot no bii3r).Surgeon has requested to use size 1 femoral distal augment-right (5540-a-102) (lot no bir3b).Patient is undergoing revision surgery due to post infected knee.Patient was on cement spacer update: stryker sales confirmed that the revision surgery completed on (b)(6).Is the second revision surgery.The first revision surgery is using non-stryker implant (cement spacer) and the date is unknown.Sales also do not have the information on the primary surgery (eg: date).Update 2 : this pi is submitted for implant found out having issue during the surgery on (b)(6) 2021.The implant was found bulged out when sales rep was installing to the femoral component before surgeon implanting into patient body.

Event Description

Is was reported by stryker sale rep that during the revision surgery, the augment (5540-a-202)(triathlon femoral distal augment-right)(lot no bds4d) was bulged out at triathlon ts femoral component left (5512-f-201)(lot no bii3r).Surgeon has requested to use size 1 femoral distal augment-right (5540-a-102)(lot no bir3b).Patient is undergoing revision surgery due to post infected knee.Patient was on cement spacer.Update: stryker sales confirmed that the revision surgery completed on 9 nov.Is the second revision surgery.The first revision surgery is using non-stryker implant ( cement spacer) and the date is unknown.Sales also do not have the information on the primary surgery ( eg: date).Update 2 : this pi is submitted for implant found out having issue during the surgery on 9 nov 2021.The implant was found bulged out when sales rep was installing to the femoral component before surgeon implanting into patient body.

Manufacturer Narrative

An event regarding incorrect selection involving a triathlon augment was reported.The event was confirmed via visual inspection of the device and the photograph provided.Method & results: product evaluation and results: visual inspection: visual inspection of the device indicated that the device was returned in used condition.There are a few minor marks and impressions on the surface of the device consistent with attempted assembly.No further surface discrepancies were observed.A photograph of the event shows the augment extending out from the edge of the femoral component.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that "during the revision surgery, the augment (5540-a-202)(triathlon femoral distal augment-right)(lot no bds4d) was bulged out at triathlon ts femoral component left (5512-f-201)(lot no bii3r) [.] surgeon has requested to use size 1 femoral distal augment-right (5540-a-102)(lot no bir3b)." the event was confirmed via visual inspection of the device and the provided photograph of the event.A review of the surgical protocol for triathlon ts knee system indicated the following: "triathlon ts augments (for triathlon ps and ts cemented femurs only) distal augments are designed for use with both the medial and lateral portions of the side indicated, e.G., #4 right is used for medial and lateral compartments on a right femur." the root cause of this event is user error as the surgeon attempted to use a #2 right femoral distal augment on a left femur.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 2 RIGHT
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12914973
• MDR Text Key: 285622701
• Report Number: 0002249697-2021-01999
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327015034
• UDI-Public: 07613327015034
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K190991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 5540-A-202
• Device Catalogue Number: 5540-A-202
• Device Lot Number: BDS4D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• 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 Race: Asian