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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POLYETHYLENE LINER; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. POLYETHYLENE LINER; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem Pain (1994)
Event Date 05/11/2017
Event Type  Injury  
Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
 
Event Description
It was reported a revision surgery was performed to convert a reflection cup with a pe liner to a reflection cup with a constrained liner due to recurrent dislocations of the hip.
 
Manufacturer Narrative
The associated complaint device was not returned for evaluation.
 
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Brand Name
POLYETHYLENE LINER
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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
yagna angirish
1450 brooks rd
memphis, TN 38116
MDR Report Key6666738
MDR Text Key78382443
Report Number1020279-2017-00471
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2017
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 Sequence Number1
Treatment
REFLECTION CUP
Patient Outcome(s) Hospitalization; Required Intervention;
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