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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. REF THREE HOLE SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH AND NEPHEW, INC. REF THREE HOLE SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71336454
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2018
Event Type  malfunction  
Event Description
It was reported that the doctor implanted the ref cup during the operation then opened the insert while it couldn't get into the cup. Under the condition that the product code was consistent with the outer cup, it was always not in place. The staff temporarily took a new set of products, but it was still can not be implanted. The doctor tried to take the product out of the body, and the insert and the cup were not in place outside the body. Finally a new outer cup was opened and the insert was rigidly implanted.
 
Manufacturer Narrative
The three hole shell was returned and evaluated. A visual inspection found light damage from attempted use on the device. The device was functionally checked and was found to work as intended. A review of the complaint history for the associated batch did not reveal additional complaints. Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. Based on this investigation, the need for corrective action is not indicated. No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary. Should additional information be received, the complaint will be reopened. We consider this investigation closed.
 
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Brand NameREF THREE HOLE SHELL 54MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH AND NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH AND NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0110148276
MDR Report Key7859888
MDR Text Key119821082
Report Number1020279-2018-01763
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K960094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71336454
Device Lot Number15AM13113
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/10/2018 Patient Sequence Number: 1
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