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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71335556
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Joint Dislocation (2374)
Event Date 05/01/2022
Event Type  Injury  
Event Description
It was reported that, after thr procedure had been performed on an unknown date, the patient experienced dislocation. This adverse event was addressed by revision surgery on (b)(6) 2022 to exchange the r3 3 hole acet shell 56mm, r3 const 56mm and cocr 12/14 fem head 22 + 8. Current health status of patient is unknown.
 
Manufacturer Narrative
Internal complaint reference: case-(b)(4).
 
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Brand NameR3 3 HOLE ACET SHELL 56MM
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 Key14485847
MDR Text Key292473125
Report Number1020279-2022-02564
Device Sequence Number1
Product Code MBL
UDI-Device Identifier03596010598264
UDI-Public03596010598264
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K070756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71335556
Device Catalogue Number71335556
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/24/2022 Patient Sequence Number: 1
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