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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 40MM X 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 40MM X 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71338680
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Osteolysis (2377); Impaired Healing (2378); Subluxation (4525); Joint Laxity (4526)
Event Date 07/09/2018
Event Type  Injury  
Manufacturer Narrative
Complaint reference: (b)(4).
 
Event Description
It was reported that the patient underwent revision surgery due to a loose, infected femoral component. During this procedure the implanted liner was removed and a antibiotic spacer was put in place. The patient then underwent revision surgery due to a spacer dislocation (5 or 6 weeks later due to timeframe of 2-stage revision). The whole s&n set being removed and replaced.
 
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Brand NameR3 0 DEG XLPE ACET LNR 40MM X 58MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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 Key10884190
MDR Text Key217642003
Report Number1020279-2020-06652
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71338680
Device Catalogue Number71338680
Device Lot Number13JM13255
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 Received06/28/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/20/2013
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: 11/23/2020 Patient Sequence Number: 1
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