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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. RF INTERFIT ACET TH SZ 54 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH AND NEPHEW, INC. RF INTERFIT ACET TH SZ 54 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71336054
Device Problems Mechanical Problem (1384); Unstable (1667); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Pain (1994)
Event Date 07/25/2018
Event Type  Injury  
Event Description
It was reported that patient complaining of a painful clunk when internally and externally rotating leg in flexion. Surgeon believes cup not medialised enough, is proud and a screw is perhaps irritating soft tissue. The cup also retroverted. Revision surgery. Range of motion was tested while patient asleep and surgeon reported stable -through original incision -opened joint to view implants surgeon felt once open that joint was dislocating too early with flexion and internal rotation. Head removed, liner removed, two screws removed and the cup explanted. Surgeon reamed deeper with a 58mm reamer, trialled a 58mm and then inserted a 58mm three hole r3 cup. A 40mm lateralised liner 20 degree hood was inserted after trialling and 40mm plus 8mm head inserted. Surgeon felt that this combination gave best range of motion and stability.
 
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Brand NameRF INTERFIT ACET TH SZ 54
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH AND NEPHEW, INC.
101 hessle road
memphis TN 38116
Manufacturer (Section G)
SMITH AND NEPHEW, INC.
101 hessle road
memphis TN 38116
Manufacturer Contact
sarah freestone
101 hessle road
memphis, TN 38116
MDR Report Key7795296
MDR Text Key117562707
Report Number1020279-2018-01538
Device Sequence Number1
Product Code MBL
UDI-Device Identifier03596010477279
UDI-Public03596010477279
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K022958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/21/2019
2 Devices were Involved in the Event: 1   2  
2 Patients were Involved in the Event: 1   2  
Date FDA Received08/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/02/2022
Device Catalogue Number71336054
Device Lot Number12EM03847
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/17/2018 Patient Sequence Number: 0
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