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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71338666
Device Problem Malposition of Device (2616)
Patient Problems Deformity/ Disfigurement (2360); Joint Dislocation (2374)
Event Date 01/06/2021
Event Type  Injury  
Event Description
It was reported that, after a tha had been performed, the patient experienced two dislocations that requiered relocation of the joint. For the third dislocation therefore patient had to be taken to the or. A revision surgery was performed to treat this event. The synergy stem was well fixed, but the surgeon felt like the r3 multi hole acetabular shell 54mm was malpositioned; therefore, it was removed. The r3 20 deg xlpe acet lnr 36mm x 58mm and cocr 12/14 fem head 36mm +0 were also removed. The surgeon repositioned the cup and implanted a redapt modular cup with or30 assembly, acetabular screws and 28mm oxinium head. Patient outcome is unknown.
 
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Brand NameR3 MULTI HOLE ACETABULAR SHELL 54MM
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 Key11250218
MDR Text Key229293151
Report Number1020279-2021-00761
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
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71338666
Device Catalogue Number71338666
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? No
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: 01/29/2021 Patient Sequence Number: 1
Treatment
COCR 12/14 FEM HEAD 36MM +0; R3 20 DEG XLPE ACET LNR 36MM X 58MM
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