MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT PS#7 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532G716

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Fluid Discharge (2686)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device 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

Patient had a total knee done at a different facility.Complaint of pain when knee is effused.Doctor examined preoperatively and at 10 degree flexion opened up medially 20 degree.Just by inserting a 7 x 19 poly, the knee was more stable.The knee was loose before surgery, was on blood thinner due to having a heart valve transplant, so effusion came easily which caused pain.Surgeon hopes a tighter knee will decrease chance of effusions.No implants were loose and broken.Left knee.

Manufacturer Narrative

An event regarding revision surgery due to pain, effusion and instability involving a triathlon ps insert 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: revision surgery took place to pain, effusion and an unstable knee whereby a thicker insert was implanted.The exact cause of the event could not be determined because insufficient information was provided.Further information such as product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded instability 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

Patient had a total knee done at a different facility.Complaint of pain when knee is effused.Dr.Examined preoperatively and at 10 degree flexion opened up medially 20 degree.Just by inserting a 7 x 19 poly, the knee was more stable.The knee was loose before surgery, was on blood thinner due to having a heart valve transplant, so effusion came easily which caused pain.Surgeon hopes a tighter knee will decrease chance of effusions.No implants were loose and broken.Left knee.

• Brand Name: X3 TRIATHLON INSERT PS#7 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5293633
• MDR Text Key: 33401740
• Report Number: 0002249697-2015-04250
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

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: 04/30/2014
• Device Catalogue Number: 5532G716
• Device Lot Number: LBL712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2009
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 105