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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71335752
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 04/08/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient has alzheimer¿s and does not comply with movement restrictions for tha.She continuously dislocates and the surgeon decided to revise to a constrained liner.There are no medical records available.
 
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Brand Name
R3 20 DEG XLPE ACET LNR 36MM X 52MM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10022593
Report Number1020279-2020-01444
Device Sequence Number2812803
Product Code MBL
UDI-Device Identifier03596010598332
UDI-Public03596010598332
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K113848
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number71335752
Device Catalogue Number71335752
Device Lot Number19MM15244
Initial Date Received by Manufacturer 04/08/2020
Supplement Date Received by Manufacturer03/03/2021
Initial Report FDA Received Date05/04/2020
Supplement Report FDA Received Date03/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age88 YR
Patient Weight52
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