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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA CLAMP PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH PATELLA CLAMP PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-3-600
Device Problems Device Reprocessing Problem (1091); Crack (1135); Degraded (1153); Peeled/Delaminated (1454); Material Integrity Problem (2978)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2016
Event Type  Malfunction  
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

Rubber on handles and impactors are cracked and peeling. Hospital has concerns that containments were being trapped in cracks and not being cleaned well enough.

 
Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies. The complaint history review indicated that there has been one other event for the reported lot. The device was returned in used condition. The handle has discolored and had tears in various areas. The event was confirmed. Visual inspection showed the device handle has discolored and had tears in various areas. The device was discovered during inspection; there was no surgical procedure associated with the reported event. This event meets the definition of preventive maintenance; no further investigation is required at this time.

 
Event Description

Rubber on handles and impactors are cracked and peeling. Hospital has concerns that containments were being trapped in cracks and not being cleaned well enough.

 
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Brand NamePATELLA CLAMP
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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5790434
MDR Text Key50176688
Report Number0002249697-2016-02309
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number6541-3-600
Device LOT NumberC3L27
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/15/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/29/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/13/2016 Patient Sequence Number: 1
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