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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP HAP 44MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

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SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP HAP 44MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120144
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 07/06/2018
Event Type  Injury  
Event Description
It was reported that a right hip revision surgery was performed due to pain and loosening of the femoral component.
 
Manufacturer Narrative
H6 codes added.
 
Manufacturer Narrative
It was reported that right hip revision surgery was performed.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.Due to lack of device details provided for the cup, and partially illegible device details provided for the head, a full documentation review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.The right side revision did not note findings related to loosening of the femoral component.The root cause of the scar tissue cannot be concluded but some patients can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined and it cannot be linked to a failure of a smith and nephew product based on the information provided.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
ACETABLR CUP HAP 44MM W/ IMPTR
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key9872149
MDR Text Key184684264
Report Number3005975929-2020-00082
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number74120144
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/24/2020
Initial Date FDA Received03/24/2020
Supplement Dates Manufacturer Received10/27/2020
10/27/2020
Supplement Dates FDA Received10/28/2020
10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age61 YR
Patient Weight230
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