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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. UNKNOWN; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 07/18/2018
Event Type  malfunction  
Event Description
It was reported that the patient suffered a dislocation in (b)(6) 2018 after a revision surgery of right total hip replacement on 2011.There is not any notification that a medical intervention or treatment was performed to correct the problem.
 
Manufacturer Narrative
The associated complaint devices were not returned.No product evaluation may be carried out.Without the device and no available device information, our investigation cannot proceed.If the device was returned or if new information is received in the future, this complaint can be re-opened.Based on this investigation, the need for corrective action is not indicated.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
UNKNOWN
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7816683
MDR Text Key118234512
Report Number1020279-2018-01644
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Date Manufacturer Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight86
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