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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F702
Device Problems Delivered as Unsterile Product (1421); Shipping Damage or Problem (1570); Device Packaging Compromised (2916); Packaging Problem (3007); Torn Material (3024)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2017
Event Type  Malfunction  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

 
Event Description

It was reported that the outer plastic packaging tore when opening the paper top of the femoral implant. The sterility of the implant was never in question prior to opening the unsterile encasing and presenting the inside sterile implant encasing to the scrub nurse. When the circulating nurse peeled back the lid of the unsterile plastic casing to present to the scrub nurse, the plastic tore and stuck to the paper covering. Because of this, the outer unsterile packaging was then in contact with the inside sterile packaging. This then renders the implant "questionable" in regards to sterility and the decision was made to not accept the implant.

 
Manufacturer Narrative

Product returned. 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 damage to the carton and outer blister. -medical records received and evaluation: not performed as the event is related to a packaging issue. -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 similar 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 whereby the carton may have been compressed and/or dropped from a height causing the damage to the carton. No further investigation for this event is required at this time.

 
Event Description

It was reported that the outer plastic packaging tore when opening the paper top of the femoral implant. The sterility of the implant was never in question prior to opening the unsterile encasing and presenting the inside sterile implant encasing to the scrub nurse. When the circulating nurse peeled back the lid of the unsterile plastic casing to present to the scrub nurse, the plastic tore and stuck to the paper covering. Because of this, the outer unsterile packaging was then in contact with the inside sterile packaging. This then renders the implant "questionable" in regards to sterility and the decision was made to not accept the implant.

 
Manufacturer Narrative

Corrected awareness date to 04/21/2017.

 
Event Description

It was reported that the outer plastic packaging tore when opening the paper top of the femoral implant. The sterility of the implant was never in question prior to opening the unsterile encasing and presenting the inside sterile implant encasing to the scrub nurse. When the circulating nurse peeled back the lid of the unsterile plastic casing to present to the scrub nurse, the plastic tore and stuck to the paper covering. Because of this, the outer unsterile packaging was then in contact with the inside sterile packaging. This then renders the implant "questionable" in regards to sterility and the decision was made to not accept the implant.

 
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Brand NameTRIATHLON CR FEM COMP #7 R-CEM
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6382609
MDR Text Key69360372
Report Number0002249697-2017-00799
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeCA
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,Followup
Report Date 06/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device Catalogue Number5510F702
Device LOT NumberEHHKY
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2014
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: 03/06/2017 Patient Sequence Number: 1
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