MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 5520-B-400

Device Problems Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon reported to the sales representative that he takes the implants in himself and he noticed that when the first layer was pulled back, that the paper on the second layer was practically stripped back as if some adhesive was stuck on it.He presumed it would be ok to use but when he went to open the packaging directly underneath this area, the packaging was not sealed i.E.The adhesive was not there.The sales representative further reported that it had presumably been stuck on the outside of the packaging and then stuck to the inner part of the outer packaging.The surgeon felt it was safer not to use the device.The packaging has been untouched by anyone else.The case was completed using a different device.

Manufacturer Narrative

An event regarding a packaging issue involving a triathlon baseplate was reported.The event was confirmed.Method & results: device evaluation and results: the outer blister lid was wrinkled.In addition, the inner blister foam was stuck to the inner blister lid.It is noted that both blisters showed evidence of complete seal transfer.There is no indication that the sterility of the device was compromised.Medical records received and evaluation: not performed as the event is not related to patient factors.Device history review: review of the device history records indicates that all 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 root cause was determined to be a known packaging issue.Packaging innovations is aware of this, and has issued a memo.

Event Description

The surgeon reported to the sales representative that he takes the implants in himself and he noticed that when the first layer was pulled back, that the paper on the second layer was practically stripped back as if some adhesive was stuck on it.He presumed it would be ok to use but when he went to open the packaging directly underneath this area, the packaging was not sealed i.E.The adhesive was not there.The sales representative further reported that it had presumably been stuck on the outside of the packaging and then stuck to the inner part of the outer packaging.The surgeon felt it was safer not to use the device.The packaging has been untouched by anyone else.The case was completed using a different device.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• 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: 5001586
• MDR Text Key: 24193489
• Report Number: 0002249697-2015-02628
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: Followup
• Report Date: 07/15/2015

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: 05/31/2020
• Device Catalogue Number: 5520-B-400
• Device Lot Number: SPUEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2015
• 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