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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 56MM

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SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 56MM Back to Search Results
Model Number 71331856
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)
Event Date 06/08/2020
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed on (b)(6) 2020 due to a right side acetabular fracture.Femoral head, acetabular liner and shell were revised.Date of initial surgery was (b)(6) 2020.
 
Event Description
It was reported that a revision surgery was performed due to a right side acetabular fracture.
 
Manufacturer Narrative
It was reported that hip revision surgery was performed.During the revision, the r3 shell, r3 liner, modular head and sleeve were removed.The stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the r3 shell, r3 liner, modular head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the r3 shell.This will continue to be monitored.Similar complaints have been identified for the r3 liner, modular head and sleeve.However, as the devices are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed, but if additional clinically relevant materials are later received the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
 
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Brand Name
R3 0 HOLE ACET SHELL 56MM
Type of Device
R3 0 HOLE ACET SHELL 56MM
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10662775
MDR Text Key210986689
Report Number1020279-2020-05332
Device Sequence Number1
Product Code MRA
UDI-Device Identifier03596010597618
UDI-Public03596010597618
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K070756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/13/2019
Device Model Number71331856
Device Catalogue Number71331856
Device Lot Number09GM08099
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/16/2020
Initial Date FDA Received10/12/2020
Supplement Dates Manufacturer Received10/28/2020
11/04/2021
Supplement Dates FDA Received11/04/2020
11/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BHR HEAD 74222144, LOT 09AW21489; MODULAR SLEEVE +8MM 12/14 / 74222400 / 07FW12490; SYN POR HO FEM COM SZ 13 / 71306113 / 09KM15760
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
Patient SexMale
Patient Weight81 KG
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