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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5536-B-400
Device Problems Break (1069); Shipping Damage or Problem (1570); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

While opening the sterile implant container onto the surgical field the nurse noticed that the plastic tub was broken off at the edge. A back up implant was immediately opened without any resulting delay.

 
Manufacturer Narrative

An event regarding packaging damage involving a tritanium baseplate was reported. The event was confirmed. Method & results: device evaluation and results: the unit carton without its shrink wrap was returned for evaluation. The opening flap/end of the unit carton was missing. Compression is visible on the side of the unit carton. Compression marks and indentation lines are visible on the back/underside of the unit carton. The outer blister was returned with the tyvek lid fully removed. One side flange was cracked/broken away from the blister. The broken section of the side flange remains attached to the tyvek lid. There is evidence of a good seal on the remaining three sides of the outer blister. The inner blister was returned fully sealed. 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 is related to a packaging issue and no adverse consequences to the patient were reported. -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 for the lot referenced. Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to opening of the packaging resulting in the damage noted. No further investigation for this event is required at this time.

 
Event Description

While opening the sterile implant container onto the surgical field the nurse noticed that the plastic tub was broken off at the edge. A back up implant was immediately opened without any resulting delay.

 
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Brand NameTRITANIUM BPLATE TRIATHLON S4
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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6559179
MDR Text Key75010553
Report Number0002249697-2017-01505
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
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 07/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5536-B-400
Device Catalogue Number5536B400
Device LOT NumberCTD13474
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/09/2017
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: 05/10/2017 Patient Sequence Number: 1
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