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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG EPF-PLUS/PLUS-FIT PE INSERT 48/28; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLY, CEMENT, UNCEMENTED
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SMITH & NEPHEW ORTHOPAEDICS AG EPF-PLUS/PLUS-FIT PE INSERT 48/28; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLY, CEMENT, UNCEMENTED Back to Search Results
Catalog Number 75010338
Device Problem Human-Device Interface Problem (2949)
Patient Problem Osteolysis (2377)
Event Date 11/27/2018
Event Type  Injury  
Event Description
It was reported a revision surgery performed due to osteolysis caused by wear of the liner.All products were replaced to oxiniun-head and third party's products.
 
Manufacturer Narrative
Investigation results: a revision surgery of a epf-plus/plus-fit pe insert was performed.No part was returned for investigation.No batch number was communicated.No medical documents was provided regarding the 13 years the implant was in-situ.Based on the available information, the reported issue could not be independently assessed.The root cause of the reported issue remains undetermined.No further actions have been initiated.If additional information becomes available in the future this investigation will be reopened.
 
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Brand Name
EPF-PLUS/PLUS-FIT PE INSERT 48/28
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLY, CEMENT, UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
oberneuhofstrasse 10d
baar 06340
SZ  06340
MDR Report Key8197633
MDR Text Key131442396
Report Number1020279-2018-02901
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number75010338
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received11/30/2018
Supplement Dates FDA Received03/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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