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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7R IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #7R IMPLANT Back to Search Results
Catalog Number 5517F702
Device Problems Shipping Damage or Problem (1570); Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916); Packaging Problem (3007)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2015
Event Type  Malfunction  
Event Description

Loan size 7 femoral triathlon implant opened by circulating nurse. Outer package noted to be cracked. Inner deemed not sterile by surgeon and scrub nurse. Additional loan item available and used.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component 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 packaging was subjected to excessive/inappropriate handling whereby the carton may have been compressed and/or dropped from a height causing the flange of the outer blister to fracture. Medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported. Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification. Complaint history review: there have been no other events for the lot referenced. Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging. No further investigation for this event is required at this time.

 
Event Description

Loan size 7 femoral triathlon implant opened by circulating nurse. Outer package noted to be cracked. Inner deemed not sterile by surgeon and scrub nurse. Additional loan item available and used.

 
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Brand NameTRIATHLON P/A CR BEADED #7R
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK (MDR)
raheen business park
limerick NA
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4851538
MDR Text Key18663450
Report Number0002249697-2015-01956
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK051380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device Catalogue Number5517F702
Device LOT NumberEMR3P
OTHER Device ID NumberSTERILE LOT: T3126
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/31/2015
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: 06/17/2015 Patient Sequence Number: 1
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