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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM46; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM46; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71335546
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 01/15/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed, exchanging liner, cup and head due to loosening of the cup.During the procedure, the stem had to be explanted since the head was completely stuck on the stem.This was not planned and there was one hour delay.
 
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Brand Name
R3 3 HOLE ACET SHELL MM46
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 Key9659931
Report Number1020279-2020-00457
Device Sequence Number16243509
Product Code MBL
UDI-Device Identifier03596010598219
UDI-Public03596010598219
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K182109
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/26/2021
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 Number71335546
Device Catalogue Number71335546
Device Lot Number19AM15736
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/15/2020
Supplement Date Received by Manufacturer08/25/2021
Initial Report FDA Received Date02/03/2020
Supplement Report FDA Received Date08/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
HEAD 71342800, LOT 19BM13249; LINER 71337546, LOT 19AM15736; HEAD 71342800, LOT 19BM13249; LINER 71337546, LOT 19AM15736
Outcome Attributed to Adverse Event Required Intervention;
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