MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #3 LM/RL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-308

Device Problems Degraded (1153); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Information (3190)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient complained of pain.Piece of cement was in the posterior aspect of the joint.Liner was removed and the cement.New liner was implanted.

Manufacturer Narrative

An event regarding wear involving a triathlon insert was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection of the explanted device was performed on the provided photographs.The image shows wear/damage to the insert.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "the primary harm involved is revision surgery due to a technical complication from the index procedure.Following implantation of the pkr in the index surgery the extruded cement was not completely removed in the posterior aspect of the articulation.This led to a mechanical complication pain necessitating revision surgery.One of the difficulties encountered and performing partial knee replacement is limited visualization afforded to the surgeon particularly in the posterior aspect of your articulation.No implant or manufacturing defect was identified in this review." -device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the investigation concluded that there was third-body wear and damage to the underside of the insert due to contact with extruded cement that was not completely removed.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient complained of pain.Piece of cement was in the posterior aspect of the joint.Liner was removed and the cement.New liner was implanted.

• Brand Name: TRIATHLON PKR INSERT X3 #3 LM/RL -8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5787408
• MDR Text Key: 49323000
• Report Number: 0002249697-2016-02248
• Device Sequence Number: 1
• Product Code: HRY
• 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: 06/14/2016

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: 06/30/2018
• Device Catalogue Number: 5630-G-308
• Device Lot Number: MMKV4P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2013
• 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: 37 YR
• Patient Weight: 87