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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 40MM ID X 56OD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 40MM ID X 56OD PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71338687
Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)
Patient Problems Fall (1848); Joint Dislocation (2374)
Event Date 06/09/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that after a total hip replacement procedure performed on 2016; the patient experienced a fall that led to several dislocations and a subsequent damage to the liner. This adverse event was treated with a revision surgery on (b)(6) 2022. The patient is currently well and recovering.
 
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Brand NameR3 20 DEG XLPE LNR 40MM ID X 56OD
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key14861223
MDR Text Key295048671
Report Number1020279-2022-03181
Device Sequence Number1
Product Code MBL
UDI-Device Identifier00885556113189
UDI-Public00885556113189
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71338687
Device Catalogue Number71338687
Device Lot Number14MM18551
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/30/2014
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: 06/29/2022 Patient Sequence Number: 1
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