• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5520-B-300
Device Problems Shipping Damage or Problem (1570); Device Packaging Compromised (2916)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 04/28/2017
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

The customer reported that as they opened up the triathlon femur packaging in [the hospital], the outside carton and shrink wrap were intact, but the white layer on top of the implant itself that is normally peeled back had detached from the plastic and the seal was breached.

 
Manufacturer Narrative

An event regarding packaging damage involving a triathlon baseplate was reported. The event was confirmed. Method & results: device evaluation and results: the unit carton with its shrink wrap opened on one side, the outer blister and the inner blister containing the device were returned for evaluation. There is severe compression and line indentations on the front of the unit carton. There is evidence of compression and line indentation along both sides of the unit carton. This evidence is an indication of excessive/inappropriate handling. The outer blister was returned with the tyvek lid fully removed from the blister pack. One of the outer blister flanges has been completely fractured off and is still adhered to the tyvek lid. This type of damage would be consistent with a shock load, e. G. The carton being dropped from a height and/or compression. There is evidence of a good seal on the remaining three sides of the outer blister. The inner blister was returned with the tyvek lid still attached. For the purpose of this investigation the tyvek lid was removed from the inner blister. There is evidence of a good seal on the inner blister. The returned device appears unremarkable. Medical records received and evaluation: not performed as the event relates to a packaging issue. Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar events reported for the lot referenced. Conclusions: based on the visual inspection of the returned packaging it appears that this component packaging was subjected to excessive/inappropriate handling whereby the carton may have been compressed and/or dropped from a height causing damage to the unit carton. No further investigation for this event is possible at this time.

 
Event Description

The customer reported that as they opened up the triathlon femur packaging in [the hospital], the outside carton and shrink wrap were intact, but the white layer on top of the implant itself that is normally peeled back had detached from the plastic and the seal was breached.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIATHLON PRIM TIB BASEPLATE - CEMENTED
Type of DevicePROSTHESIS, 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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6597509
MDR Text Key76381436
Report Number0002249697-2017-01713
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5520-B-300
Device LOT NumberBTR7T
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/15/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/30/2017 Patient Sequence Number: 1
-
-