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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 15MM PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT

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SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 15MM PROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT Back to Search Results
Model Number 71332515
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Injury (2348)
Event Date 10/25/2019
Event Type  Injury  
Event Description
It was reported that revision surgery was performed for the third time. Aseptic loosening. Hip prepped and draped, jointly opened, specimens taken. Joint lavaged and debrided intensely. The femoral head removed, poly liner and cup and screws removed. Existing socket reamed to a bleeding bone bed. Implant trialed, joint lavaged again with hydrogen peroxide and more saline. Definitive acetabular implant inserted with bone cement. Tripolar liner/head trialed via reduction, hip stable, definitive tripolar implants inserted and hip reduced, hip closed. No more information is available.
 
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Brand NameREF SPHER HEAD SCREW 15MM
Type of DevicePROSTHSIS, HIP, SMI-CONSTRAIND, UNCMNTD, MTL/PLYMR, NN-PRS, CALICUM-PHSPHT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9360066
MDR Text Key167548577
Report Number1020279-2019-04133
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K990666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71332515
Device Catalogue Number71332515
Device Lot Number13MM11402
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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