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-502

Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that upon opening the implant, a stain-like substance was present on the unit.

Manufacturer Narrative

An event regarding a stain on a femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: the femoral component was returned wrapped in a plastic bag inside its unit carton.No blister packs were returned with the device.There is evidence of staining on the internal fixation surface of the lateral condyle, around the threaded hole.The bearing surface of the femoral component appears unremarkable.-medical records received and evaluation: not performed as no medical records were provided.-device history review: indicated that 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: the investigation concluded that the stain is a result of a water mark that remained after the cleaning process and affected a small percentage of triathlon ps parts.New holding baskets were introduced in the clean and passivate lines layton 1 & 2 without prior change control approval.The design of the new holding baskets along with the triathlon ps part geometry and insufficient drying on layton 1 contributed to the retention of water on the part which led to the eventual water marking of the parts over time.The staining was not obvious immediately and occured over time.The mark is currently a part of a visual standard inspection post passivation.An nc was issued on 24 - nov - 2016 for stain on femoral component triathlon ps parts and closed on 31 january 2017.A subsequent capa was raised on 08-dec-2016.All corrective actions have been implemented to prevent a recurrence of the non-conformance.A severity assessment was completed on the stain, resulting in a very low risk rating.Organic residual testing, endotoxin (lal) testing and cytotoxicity testing were all complete.No issues were reported.This product was deemed safe for intended use.No further investigation for this event is required at this time.

Event Description

It was reported that upon opening the implant, a stain-like substance was present on the unit.

• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6443072
• MDR Text Key: 71392368
• Report Number: 0002249697-2017-01044
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050400
• UDI-Public: (01)07613327050400(11)160925(17)210930(10)BH63J
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 5515-F-502
• Device Lot Number: BH63J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2016
• 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