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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7L PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7L PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5517-F-701
Device Problems Break (1069); Shipping Damage or Problem (1570)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 05/03/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The implant shell is damaged while the outer box is not impaired.

 
Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component was reported. The event was confirmed. Method & results: device evaluation and results: the unit carton was returned without the shrink wrap. There is damage to one of the opening ends of the unit carton with evidence of compression marks and line indentations. 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 full seal existing between the tyvek lid and the outer blister flanges on the remaining sides. The inner blister was returned full sealed. For the purpose of this investigation the tyvek lid was removed from the inner blister. There is evidence of a full seal existing between the tyvek lid and the inner blister flanges. 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 implant shell is damaged while the outer box is not impaired.

 
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Brand NameTRIATHLON P/A CR BEADED #7L
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 Key6597506
MDR Text Key76381335
Report Number0002249697-2017-01710
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,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 MODEL Number5517-F-701
Device Catalogue Number5517F701
Device LOT NumberBAS9C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/14/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/22/2016
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
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