MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #6R; IMPLANT

Catalog Number 5517F602

Device Problems Device Contamination With Biological Material (2908); Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

When opening the implant for the dr.By the circulating nurse, the scrub tech noticed a hair in the first blister of the implant.Scrub requested new implant which was grabbed by the rep and then opened by the circulating nurse.

Manufacturer Narrative

Additional information has been requested.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding a hair found on top of the tyvek lid of the inner blister involving a triathlon femoral component was reported.The event was confirmed.Method and results: visual inspection confirmed the presence of a hair lying on top of the tyvek lid of the inner blister.However, it could not be determined when the hair had fallen into the packaging as the tyvek lid of the outer blister had already been opened when the product was received back in (b)(4) for review.The device was manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Conclusions: the investigation concluded that the presence of a hair in the outer blister of the implant may have been caused in the packaging department where the operator may have failed to detect foreign matter in the blister.

Event Description

When opening the implant for the dr.By the circulating nurse, the scrub tech noticed a hair in the first blister of the implant.Scrub requested new implant which was grabbed by the rep and then opened by the circulating nurse.

• Brand Name: TRIATHLON P/A CR BEADED #6R
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK (MDR); raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4867102
• MDR Text Key: 6043447
• Report Number: 0002249697-2015-02061
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 5517F602
• Device Lot Number: EMSRF
• Other Device ID Number: STERILE LOT: T3101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2015
• 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
• Patient Age: 60 YR