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-509

Device Problems Unstable (1667); Material Deformation (2976); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Approximately 16-18 months ago, patient had a triathlon ps knee put in for instability.5-9 insert removed due to wear.Lots of wear on the post.Locking mechanism posteriorly did not seat.Doctor put in a 5-11 insert.

Manufacturer Narrative

Reported event: an event regarding wear involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: material analysis has been performed on the received devices that states "scratching, burnishing, and third body indentations were observed on the insert, which are common forms of damage modes in (b)(4).Abrasion was also observed on the post of the insert, consistent with contact from the femoral component.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "inadequate soft tissue balancing at the primary total knee arthroplasty likely resulted in postoperative instability and insert post impingement and accelerated wear.There is no evidence of design, manufacturing or material defects contributing to this clinical situation." device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the provided medical records were reviewed by a consulting clinician who indicated: "inadequate soft tissue balancing at the primary total knee arthroplasty likely resulted in postoperative instability and insert post impingement and accelerated wear.There is no evidence of design, manufacturing or material defects contributing to this clinical situation." no further investigation for this event is possible at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.

Event Description

Approximately 16-18 months ago, patient had a triathlon ps knee put in for instability.5-9 insert removed due to wear.Lots of wear on the post.Locking mechanism posteriorly did not seat.Doctor put in a 5-11 insert.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5762379
• MDR Text Key: 48569476
• Report Number: 0002249697-2016-02153
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

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: 05/31/2012
• Device Catalogue Number: 5532-G-509
• Device Lot Number: 27EMJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2007
• 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