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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 3 HOLE ACET SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW ORTHOPAEDICS LTD R3 3 HOLE ACET SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71335554
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 01/28/2016
Event Type  Injury  
Manufacturer Narrative
Part details amended to reflect event & investigation.
 
Manufacturer Narrative
(b)(4). Customer indicated that there is no product/device to be returned for investigation analysis.
 
Event Description
It was reported a scheduled removal of a sno metal liner was performed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Revised due to grossly loose cup. Left hip.
 
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Brand NameR3 3 HOLE ACET SHELL 54MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa TN CV31 3HL
UK CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa TN CV31 3HL
UK CV31 3HL
Manufacturer Contact
claudia odoy
schachenallee 29
aarau, TN 5001
SZ   5001
9013995009
MDR Report Key5404297
MDR Text Key108656575
Report Number1020279-2016-00096
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Patient
Type of Report Initial,Followup,Followup,Followup
Report Date 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/08/2018
Device Catalogue Number71335554
Device Lot Number08LM05171
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/02/2016 Patient Sequence Number: 1
Treatment
74222100/08BW15651
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