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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN INSERT SIZE 11 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN INSERT SIZE 11 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2019
Event Type  Injury  
Manufacturer Narrative

An event regarding size/fit issue involving an unknown insert was reported. The event was not confirmed. Method & results:  device evaluation and results: not performed as product was not returned.   clinician review: no medical records were received for review with a clinical consultant.    device history review: not performed as no lot information was provided. Complaint history review: not performed as no lot information was provided. Conclusion: the exact cause of the event could not be determined because insufficient information was provided.   additional information including device details, return of the device, photographs/video of the event as it happened and operative reports are required to fully investigate the event and determine a root cause. If further information becomes available or the product is returned, this investigation will be re-opened. Device not returned.

 
Event Description

During a tka case. Surgeon trialed a size 10 poly insert and put in the implant however the surgeon said that it didn't feel the same. The surgeon did the same procedure with a size 11 and did not like the implant and so he used a size 12 trail and liked the implant size. There is no additional information can be provided by the surgeon or hospital. No additional information will be available.

 
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Brand NameUNKNOWN INSERT SIZE 11
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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9307216
MDR Text Key166140765
Report Number0002249697-2019-03729
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 11/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/11/2019 Patient Sequence Number: 1
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