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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71337650
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 11/07/2018
Event Type  Injury  
Event Description
It was reported that the patient fell and dislocated her hip.Surgeon performed a revision surgery to change the head and the poly as well in case of damage due to the dislocation.
 
Manufacturer Narrative
The associated complaint device was not returned.A clinical analysis indicated that no relevant clinical medical information was provided to conduct a thorough medical assessment.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.Should additional information be received, the complaint will be reopened.
 
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Brand Name
R3 20 DEG XLPE ACET LNR 32MM X 50MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8074496
MDR Text Key127268111
Report Number1020279-2018-02499
Device Sequence Number1
Product Code MBL
UDI-Device Identifier03596010598486
UDI-Public03596010598486
Combination Product (y/n)N
PMA/PMN Number
K113848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71337650
Device Lot Number17MM12525
Date Manufacturer Received11/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
71337650 / 17MM12525
Patient Outcome(s) Hospitalization; Required Intervention;
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