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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71338664
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 06/05/2018
Event Type  Injury  
Event Description
Revision surgery was performed due to dislocation. The surgeon deemed that the cause of this failure was cup malalignment. The surgeon does not fault the device. The product is not available. No more information available.
 
Manufacturer Narrative
The associated complaint device was not returned. A clinical evaluation was conducted and it was reported a revision surgery was performed due to dislocation. The surgeon deemed that the cause of this failure was cup malalignment. No clinical relevant documents were provided to conduct a thorough medical assessment, nor will the product be provided for evaluations. The impact to the patient beyond the revision cannot be determined. No further clinical/medical assessment is warranted at this time. A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode. In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident. Device history record review confirmed that all released parts met specifications applicable at the time of production. 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. No further actions are being taken at this time. We consider this investigation closed.
 
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Brand NameR3 MULTI HOLE ACETABULAR SHELL 50MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7657629
MDR Text Key112990916
Report Number1020279-2018-01263
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
PMA/PMN Number
K092386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71338664
Device Lot Number17HW18138
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/03/2018 Patient Sequence Number: 1
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