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-501

Device Problems Device Contamination With Biological Material (2908); Device Packaging Compromised (2916); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

The circulator opened # 5515-f-501 to the surgical tech.The surgical tech noticed a black hair on the inside of the packaging.The hair was visually confirmed by all surgical team members.To my eye, it appeared the hair was sticking to the yellow band on the interior portion of the plastic packaging.I opened a new # 5515-f-501 and the one with a hair in the packaging was passed off to the circulator.The contaminated packaging was never placed on the sterile field.

Manufacturer Narrative

An event regarding a foreign object found in the packaging involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: the device was returned without the original packaging box.The inner blister was returned without the lid.The implant looks unremarkable.There is no signs of hair found on the returned device.-medical records received and evaluation: not performed as there is no evidence to support the event was related to patient factors.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the device was returned without the original packaging box.The inner blister was returned without the lid.The implant looks unremarkable without no signs of hair/foreign object found on the returned device, therefore the reported event could not be confirmed.

Event Description

The circulator opened # (b)(4) to the surgical tech.The surgical tech noticed a black hair on the inside of the packaging.The hair was visually confirmed by all surgical team members.To my eye, it appeared the hair was sticking to the yellow band on the interior portion of the plastic packaging.I opened a new #(b)(4) and the one with a hair in the packaging was passed off to the circulator.The contaminated packaging was never placed on the sterile field.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5914186
• MDR Text Key: 54266936
• Report Number: 0002249697-2016-02786
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Catalogue Number: 5515-F-501
• Device Lot Number: VH4ZD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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
• Patient Age: 70 YR