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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 190MM SZ 16 HO PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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SMITH & NEPHEW, INC. REDAPT SLVLS MONO STEM 190MM SZ 16 HO PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 71354483
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Joint Dislocation (2374)
Event Date 04/10/2019
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that, as part of an unspecified medical indication, a patient underwent a thr revision surgery on the right hip on (b)(6) 2018. During this procedure, a redapt slvls mono stem 190mm sz 16 ho was implanted. 1 year postoperatively, the patient underwent a second revision surgery due to a dislocation following a fall. It is unknown which devices were explanted and which devices were implanted in exchange. The contribution of redapt slvls mono stem 190mm sz 16 ho to the reported adverse event could not be discarded at this time. Additional details about the implanted prosthesis before the second revision surgery was performed are not available. As the data collection has been done retrospectively and is anonymized, further details on the patient's final outcome are unknown.
 
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Brand NameREDAPT SLVLS MONO STEM 190MM SZ 16 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 Key12548864
MDR Text Key273878216
Report Number1020279-2021-07110
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71354483
Device Catalogue Number71354483
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 Received10/26/2021
Was Device Evaluated by Manufacturer? No
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: 09/29/2021 Patient Sequence Number: 1
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