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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 46MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 46MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71331946
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 10/21/2021
Event Type  Injury  
Event Description
It was reported that, after a right thr surgery had been performed on (b)(6) 2021, the patient experienced a dislocation of the right. This adverse event was solved by revision surgery on (b)(6) 2021, in which a r3 3 hole ha ctd acet shell 46mm, ref spher head screw 40mm, two(2) ref spher head screw 30mm, a cocr 12/14 fem head 28 +0 and a r3 0 deg xlpe acet lnr 28mm x 46mm were explanted. Current health status of patient is unknown.
 
Manufacturer Narrative
Internal complaint reference case (b)(4).
 
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Brand NameR3 3 HOLE HA CTD ACET SHELL 46MM
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 Key12799348
MDR Text Key280846150
Report Number1020279-2021-08078
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K201701
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71331946
Device Lot Number17JM06307
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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