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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE TIBIAL ROTATING COMPONENT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STANMORE IMPLANTS WORLDWIDE TIBIAL ROTATING COMPONENT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number UNK_STM
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2022
Event Type  malfunction  
Event Description
Stryker rep reported there were holes in the packaging of custom made components: "there was a packaging issue with pin 22902, operation date 16th march. There was a hole in the outer packaging of the rotating component that was noticed before the surgery started. This didn't compromise the operation as they had a mets component on the shelf. There was also a hole in both outer and inner wrapping of the custom proximal tibia component. This wasn't noticed until the implant was opened. The surgeon spoke to colleagues and followed advice to clean the custom tibia and implant into the patient. ".
 
Manufacturer Narrative
The reported device is similar to a device approved for compassionate use in the united states. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
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Brand NameTIBIAL ROTATING COMPONENT
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK WD6 3SJ
Manufacturer (Section G)
STANMORE IMPLANTS WORLDWIDE
210 centennial avenue
centennial park, elstree
borehamwood WD6 3 SJ
UK WD6 3SJ
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key14056791
MDR Text Key289973292
Report Number3004105610-2022-00055
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_STM
Device Lot NumberPIN 22902
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2022
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: 04/08/2022 Patient Sequence Number: 1
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