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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF FSO CER ACET COMP 50MM; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED
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SMITH & NEPHEW, INC. RF FSO CER ACET COMP 50MM; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED Back to Search Results
Catalog Number 71332050
Device Problem Noise, Audible (3273)
Patient Problem Injury (2348)
Event Date 08/15/2019
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to squeaking on (b)(6) 2019.Cup, liner and head were explanted and replaced with new components.Primary surgery was performed on (b)(6) 2008.
 
Manufacturer Narrative
The associated complaint devices were not returned.The medical investigation concluded that no clinical information has been provided for inclusion in this medical investigation.Should any additional medical information be provided these complaints will be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
 
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Brand Name
RF FSO CER ACET COMP 50MM
Type of Device
PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8967578
MDR Text Key156709159
Report Number1020279-2019-03284
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
PMA/PMN Number
P030022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71332050
Initial Date Manufacturer Received 08/15/2019
Initial Date FDA Received09/05/2019
Supplement Dates Manufacturer Received08/15/2019
Supplement Dates FDA Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age25 YR
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