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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BIPOLAR BALL HEAD COCR 44/28; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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SMITH & NEPHEW ORTHOPAEDICS AG BIPOLAR BALL HEAD COCR 44/28; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 16762
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Code Available (3191)
Event Date 08/23/2013
Event Type  Injury  
Event Description
Revision surgery was performed due to migration of bipolar head.The surgeon thinks that the cause of this failure is technical error.
 
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Brand Name
BIPOLAR BALL HEAD COCR 44/28
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
oberneuhofstrasse 10d
baar 6340
SZ  6340
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau 5001
SZ   5001
Manufacturer Contact
claudia odoy
0628320660
MDR Report Key4804066
MDR Text Key5829481
Report Number9613369-2015-00034
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K982447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date11/23/2017
Device Model Number16762
Device Catalogue Number75004340
Device Lot NumberB1024636
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/29/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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