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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SERF PROSTHESIS, HIP, SEMI-CONSTRAINED

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SERF PROSTHESIS, HIP, SEMI-CONSTRAINED Back to Search Results
Catalog Number RM54202853
Device Problems Unsealed Device Packaging; Incomplete or Missing Packaging; Tear, Rip or Hole in Device Packaging; Packaging Problem
Event Date 08/23/2018
Event Type  Malfunction  
Event Description

During a hip surgery on (b)(6) 2018, an implant was to be used but found to be partially opened during the case. The implant was not used and sent to manufacturer to investigate.

 
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Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED
Manufacturer (Section D)
SERF
85 avenue des bruyeres
decines cedex, 69153
FR  69153
MDR Report Key7902705
Report Number1226188-2018-00135
Device Sequence Number1
Product CodeLZO
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRM54202853
Device LOT Number1610369A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/30/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/24/2018
Device Age2 yr
Event Location Hospital
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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