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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71338665
Device Problems Calibration Problem (2890); Unintended Movement (3026)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 01/02/2019
Event Type  malfunction  
Event Description
It was reported that after a total hip replacement procedure, post operative film showed that the screw had gone completely through the shell. No delay reported. No revision surgery performed.
 
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Brand NameR3 MULTI HOLE ACETABULAR SHELL 52MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key8279016
MDR Text Key134132119
Report Number1020279-2019-00291
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2018
Device Catalogue Number71338665
Device Lot Number18JM17694
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 Received09/28/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2018
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: 01/25/2019 Patient Sequence Number: 1
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