MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520-B-600

Device Problems Material Discolored (1170); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The scrub nurse and surgeon were concerned that when the triathlon device was being opened during the case, the packaging was allegedly slightly wrinkled and discolored.The customer further reported that the device had not been handed on to the table at the time so they were able to open another device and proceed as normal.

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 released a memo regarding lidstock/foam sticking complaints dated 25-sep-2009 stating: stryker orthopaedics currently utilizes a void-filling approach to sterile product packaging.Product is placed in the package and supported with foams of various sizes, and these configurations are then validated.The foam serves to protect both the product and the package, preventing the product from moving within the package and damaging the sterile barrier.As the purpose of the foam is to tightly constrain the product, these package configurations are designed to reduce open space.As a result of this critical design function, sporadic issues of foam sticking to the package tyvek lidstock have been reported.Due to the infrequent nature of these complaints and the greater risk that would be presented by an undersized foam, these complaints will not be addressed through a design change.

Event Description

The scrub nurse and surgeon were concerned that when the triathlon device was being opened during the case, the packaging was allegedly slightly wrinkled and discolored.The customer further reported that the device had not been handed on to the table at the time so they were able to open another device and proceed as normal.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5069677
• MDR Text Key: 26009274
• Report Number: 0002249697-2015-02965
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/13/2015

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: 06/30/2020
• Device Catalogue Number: 5520-B-600
• Device Lot Number: SOGUD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2015
• 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