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-300

Device Problems Device Damaged Prior to Use (2284); Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/04/2015

Event Type  malfunction  

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.

Event Description

During the implant timeout, we noticed that the implant packaging from national loaners appeared to be compromised.We opened anyway and noticed a white film on the inner packaging and on the keel of the implant.The scrub tech passed off the implant and we opened another.

Manufacturer Narrative

An event regarding packaging damage involving a triathlon baseplate was reported.The event was confirmed.Method & results: device evaluation and results:based on the visual inspection of the returned packaging it appears that this component was subjected to excessive/inappropriate handling which subsequently allowed relative movement between the device and its packaging causing scuffing within the inner blister.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: chr review determined that there were no similar events reported for the lot.Conclusions: based on the visual inspection of the returned packaging it appears that this component was subjected to excessive/inappropriate handling which subsequently allowed relative movement between the device and its packaging causing scuffing within the inner blister.No further investigation for this event is possible at this time.

Event Description

During the implant timeout, we noticed that the implant packaging from national loaners appeared to be compromised.We opened anyway and noticed a white film on the inner packaging and on the keel of the implant.The scrub tech passed off the implant and we opened another.

• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5315793
• MDR Text Key: 34767131
• Report Number: 0002249697-2015-04405
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 5520-B-300
• Device Lot Number: S84HF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2014
• 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: 86 YR