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 Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2016

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

It was reported that, during a tka, when a surgeon opened the inner blister pack, he found some powder on the tibial base plate.He rinsed and implanted on a patient.

Manufacturer Narrative

An event regarding white debris generated within the inner sterile blister pack involving a triathlon baseplate component was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection confirmed the presence of white debris within the inner blister.It was determined that the debris was generated as a result of excessive vibration/movement of the baseplate component, leading to scuffing of the blister where the component came into contact with it.The white debris is petg powder from the blister pack.Medical records received and evaluation: medical review was not performed as this event relates to a packaging issue.The device in question was implanted.Device history review: dhr review was satisfactory.Complaint history review: chr review confirmed that there were no other similar reported events for the lot.Conclusions: the investigation concluded that the white debris within the pack was caused by excessive movement/vibration of the component within the inner blister pack leading to scuffing of the pack and the generation of petg powder shavings.No further investigation for this event is possible at this time.

Event Description

It was reported that, during a tka, when a surgeon opened the inner blister pack, he found some powder on the tibial base plate.He rinsed and implanted on a patient.

• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5649345
• MDR Text Key: 45121710
• Report Number: 0002249697-2016-01580
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• 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: 04/15/2016

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: 11/30/2018
• Device Catalogue Number: 5520-B-600
• Device Lot Number: EFSYF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• 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