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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 Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 06/19/2018
Event Type  Injury  
Event Description
It was reported the patient was readmitted to hospital post op following pain. Notes indicated that it may have dislocated. The acetabular and femoral component were well fixed. The liner and cup were removed and replaced with a subsequent companies implants. The head was also removed and exchanged, multiple samples were collected and sent to pathology.
 
Manufacturer Narrative
The associated complaint devices were not returned. The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.  no medical assessment is warranted at this time.  this complaint will be re-evaluated if more information becomes available. A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes. A review of complaint history for the listed parts revealed no prior complaints for the listed batches. Without the actual product involved, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. We consider this investigation closed.
 
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Brand NameR3 20 DEG XLPE ACET LNR 32MM X 50MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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
MDR Report Key7631748
MDR Text Key112132495
Report Number1020279-2018-01179
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K113848
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 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71337650
Device Lot Number18AM04802
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 Received06/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2018
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: 06/22/2018 Patient Sequence Number: 1
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