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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 44MM ID X 60 OD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 44MM ID X 60 OD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71331106
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2019
Event Type  malfunction  
Event Description
It was reported that during a thr procedure, impacting surface broke off. No confirmation of delay has been received. Backup device available. No injury or impact to patient reported.
 
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Brand NameR3 20 DEG XLPE LNR 44MM ID X 60 OD
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 Key8819051
MDR Text Key152015575
Report Number1020279-2019-02726
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71331106
Device Lot Number18CM23549
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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