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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71332752
Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 06/21/2018
Event Type  Injury  
Event Description
Revision surgery was performed due to dislocation. The cause of dislocation was impingement of acetabular osteophytes. The surgeon does not fault the device. The product is not available. No more information available.
 
Manufacturer Narrative
The associated r3 acetabular insert was not returned for evaluation. Our investigation including a review of complaint history on the list part revealed no additional complaints for this failure mode with the same batch number. A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes. A clinical evaluation noted that no clinical information was provided for inclusion in this investigation. The future impact to the patient beyond the revision cannot be determined.  no further clinical/medical assessment is warranted at this time. Without the return of the actual product involved, our investigation of this report is inconclusive. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary. We consider this investigation closed. Should additional information be received, the complaint will be reopened.
 
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Brand NameR3 0 DEG XLPE ACET LNR 36MM X 52MM
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
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
MDR Report Key7716749
MDR Text Key114930241
Report Number1020279-2018-01392
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeJA
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 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71332752
Device Lot Number15GM05282
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 Received07/10/2018
Was Device Evaluated by Manufacturer? No
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: 07/24/2018 Patient Sequence Number: 1
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