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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACETABULAR LINER 36MM X 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 0 DEG XLPE ACETABULAR LINER 36MM X 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71335754
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 11/04/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that revision surgery was performed due to infection.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
The associated complaint devices were not returned for evaluation.
 
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Brand NameR3 0 DEG XLPE ACETABULAR LINER 36MM X 54MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key6127160
MDR Text Key60851482
Report Number1020279-2016-00908
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71335754
Device Lot Number13DM06454
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2013
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: 11/25/2016 Patient Sequence Number: 1
Treatment
ACETABULAR SCREW, # (B)(4), LOT # 11HT09906; FEMORAL HEAD, # (B)(4), LOT # 13MM07270; MODULAR NECK, # (B)(4), LOT # 12LTM005C
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