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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM +0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

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SMITH AND NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM +0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71343600
Device Problems Mechanical Problem (1384); Unstable (1667); Appropriate Term/Code Not Available (3191)
Patient Problem 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 NameOXINIUM FEM HD 12/14 36 MM +0
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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 Number0
Product Code JDI
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 Catalogue Number71343600
Device Lot Number16KM02964
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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