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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 Clamp (757); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

During tka surgery, the surgeon attached the clamp cap and cement cap to the patella clamp. During the cement fixation, compression with the patella clamp was loose.

 
Manufacturer Narrative

An event regarding nonfunctional involving a patella clamp was reported. The event was not confirmed. Method and results: device evaluation and results: a functional inspection was conducted on the patella clamp (6541-3-600, lot er6na7). The thumb ratchet lever seems to catch the teeth and release properly on the device. The clamp base (65411-3-801, lot mc7c20) and cement cap (6541-3-800, lot rs6l03) was attached to the patella clamp. Both devices were locked in the patella clamp and did not come out. Both devices locked as intended. A patella (5550-g-360, lot y752) and foam was used to clamp down the patella. When the patella and foam were clamped together nothing came loose. We swapped the cement cap and clamp base and retried the previous test and had the same results, nothing came loose. Medical records received and evaluation: not performed as there are no medical records. Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for this lot. Conclusions: the exact cause of the event could not be determined because the complaint issue of the patella clamp being loose, could not be replicated. A functional inspection was conducted on the returned products and the devices functioned as intended.

 
Event Description

During tka surgery, the surgeon attached the clamp cap and cement cap to the patella clamp. During the cement fixation, compression with the patella clamp was loose.

 
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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 Key5926390
MDR Text Key54526858
Report Number0002249697-2016-02845
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK123486
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 08/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-3-600
Device LOT NumberER6NA7
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/02/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/27/2012
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: 09/02/2016 Patient Sequence Number: 1
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