MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5515-F-402

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)

Patient Problems No Patient Involvement (2645); No Code Available (3191)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

It is reported by quality department of the (b)(6) company dot that four of the received implants shows material discrepancies.

Manufacturer Narrative

An event regarding a surface defect involving a triathlon ps fem component, cemented was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection confirmed the reported event of a surface defect on the articulating surface of the femoral condyle.An inspection of the surface defect by the quality engineer in the triathlon femoral cell on the unit reported within this investigation was completed and was deemed to be unacceptable based upon the criteria specified on d00400 'visual inspection specification for implantable femoral components' version 8.Material analysis on the surface defect confirmed that there was an inclusion on the bearing surface of the returned unit within this investigation.Medical records received and evaluation: not performed as the event relates to the surface defect on the device and the device was not implanted.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.Conclusions: based on inspection by the quality engineer in the triathlon femoral cell it was found that surface defect, on the returned unit within this investigation, was deemed to be unacceptable as per the criteria specified on d00400 'visual inspection specification for implantable femoral components' version 8.Material analysis on the surface defect confirmed that the bearing surface had an inclusion on it.No further investigation is possible at this time.

Event Description

It is reported by quality department of the (b)(4) that four of the received implants shows material discrepancies.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• 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: 5291010
• MDR Text Key: 33871924
• Report Number: 0002249697-2015-04212
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 5515-F-402
• Device Lot Number: AMR3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• 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