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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).
 
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 was explanted.Current health status of patient is unknown.
 
Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.B5.
 
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Brand Name
R3 3 HOLE HA CTD ACET SHELL 46MM
Type of Device
PROSTHESIS, 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 Physician
Type of Report Initial,Followup
Report Date 02/07/2022
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 Health Professional
Device Catalogue Number71331946
Device Lot Number17JM06307
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/21/2021
Initial Date FDA Received11/11/2021
Supplement Dates Manufacturer Received02/04/2022
Supplement Dates FDA Received02/07/2022
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
Patient Sequence Number1
Treatment
71332530/REF SPHER HEAD SCREW 30MM; 71332530/REF SPHER HEAD SCREW 30MM; 71332540/REF SPHER HEAD SCREW 40MM
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