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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71337650
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Dislocation (2374)
Event Date 03/29/2021
Event Type  Injury  
Event Description
It was reported that, after a thr had been performed on (b)(6) 2017, the patient experimented multiple dislocations recently. This adverse event was addressed through revision surgery to exchange liner and head. Given that the size of r3 cup is 50 mm and, therefore, not able to take a constrained liner, it the r3 cup was also removed. The patient outcome is unknown.
 
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Brand NameR3 20 DEG XLPE ACET LNR 32MM X 50MM
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
1450 brooks road
memphis, TN 38116
5123913905
MDR Report Key11722120
MDR Text Key247215266
Report Number1020279-2021-03423
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K113848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71337650
Device Catalogue Number71337650
Device Lot Number17BM00789
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 Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2017
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: 04/25/2021 Patient Sequence Number: 1
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