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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT, NAV 22/55; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT, NAV 22/55; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 75023362
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 12/04/2019
Event Type  malfunction  
Event Description
It was reported that liner trial broke in multiple pieces during implant final impaction.Unknown delay occurrence.No backup was available.
 
Manufacturer Narrative
A polarcup trial insert, nav 22/55 was reported because the part broke in pieces during implant final impaction.It assumed that the device was used in surgery.The complaint device was not returned for investigation.The failure mode could not be confirmed.Review of the production documentation and the complaint history review could not be performed since the production lot number is unknown.Based on the conducted investigation the root cause of the failure could not be determined conclusively.Further investigations have been initiated to better understand the issue.Smith+nephew will continue to monitor for similar issues.
 
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Brand Name
POLARCUP TRIAL INSERT, NAV 22/55
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
oberneuhofstrasse 10d
baar 06340
SZ  06340
MDR Report Key9537004
MDR Text Key187015750
Report Number9613369-2019-00110
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07611996112511
UDI-Public07611996112511
Combination Product (y/n)N
PMA/PMN Number
K110135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number75023362
Device Catalogue Number75023362
Was Device Available for Evaluation? No
Date Manufacturer Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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