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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVD MONO STEM 300MM SZ 13 HO PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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SMITH & NEPHEW, INC. REDAPT SLVD MONO STEM 300MM SZ 13 HO PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 71354855
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 09/07/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, after a thr surgery performed on (b)(6) 2018, the patient presented to hospital with a significant infection and an abscess of his right hip extending distally to approximately 10cm proximal to the knee. This adverse situation was treated with a revision surgery performed on (b)(6) 2021, where the redapt 300mm sleeved revision stem size 13 high offset, the redapt modular sleeve medium size 12-13 stiktite with hydroxyapatite and the biolox delta head 36 mm 12/14 long / +8 were removed. Current health status of the patient is unknown.
 
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Brand NameREDAPT SLVD MONO STEM 300MM SZ 13 HO
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12537679
MDR Text Key273527440
Report Number1020279-2021-07202
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K162303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71354855
Device Catalogue Number71354855
Device Lot Number16MTM0072J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/04/2017
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: 09/27/2021 Patient Sequence Number: 1
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