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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-G-309
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  malfunction  
Manufacturer Narrative
Review of the product history records indicates products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Surgeon's preference is to hold the poly until the cement has hardened.All surgical staff are in stryker hoods & helmets, at all times.The tibial insert was confirmed by the surgeon.Inner, sterile, package delivered to the field appropriately by the circulating rn.Inner package remained intact until he opened it.Surgeon proclaimed, "there is a hair on the insert." i was then shown the insert.On the anterior aspect of the poly, near the retention wire was a hair.I responded with, "please, pass the insert off the field.I will get another." insert was placed in a specimen container.Which was subsequently returned to the original packaging, along with the remaining stickers.
 
Manufacturer Narrative
An event regarding a hair found in the packaging involving a triathlon insert was reported.The event was confirmed.Conclusions the reported event was confirmed and the root cause was determined to be a manufacturing non-conformance.Nc raised on 20-jul-2018 regarding the stray hair found on the implant and to define the root cause and corrective actions.Corrective action/preventive action: it was concluded that the stray hair had no effect on the quality, functionality, or sterility of the implant.The product was not used in surgery and a backup unit was immediately available for implant, causing only a five (5) minute delay to surgery.There is nothing in the packaging process that would inherently cause the hair to reoccur on each piece of the lot.Therefore, we are confident that the scope can be restricted to just this one piece.This is based on the 100% verification of each product individually, proper gowning procedures in the packaging areas, and the independent sealing process within the room.In addition, (b)(4) allows for an occurrence of foreign material within the blister of 1 in 5,000 parts, which is well within the expected rates of manufacturing.
 
Event Description
Surgeon's preference is to hold the poly until the cement has hardened.All surgical staff are in stryker hoods & helmets, at all times.The tibial insert was confirmed by the surgeon.Inner, sterile, package delivered to the field appropriately by the circulating rn.Inner package remained intact until he opened it.Surgeon proclaimed, "there is a hair on the insert." i was then shown the insert.On the anterior aspect of the poly, near the retention wire was a hair.I responded with, "please, pass the insert off the field.I will get another." insert was placed in a specimen container.Which was subsequently returned to the original packaging, along with the remaining stickers.
 
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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
MDR Report Key7675517
MDR Text Key113622694
Report Number0002249697-2018-02120
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327050646
UDI-Public07613327050646
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Catalogue Number5532-G-309
Device Lot Number9V2Y5W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Date Manufacturer Received07/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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