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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM48 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL MM48 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71335548
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/11/2018
Event Type  malfunction  
Event Description
It was reported that during artificial hip replacement surgery, screws were used for fixation and one of the screws passed directly through the acetabulum cup, surgeon used another two screws for fixation. One of the screws was left in the patient.
 
Manufacturer Narrative
The associated complaint device was not returned. A visual examination was unable to be performed without the actual device; only the outer box was the returned. A clinical analysis indicated that the provided x-ray confirms 3 retained screws embedded in the bone with one completely through the shell. The root cause of the reported issue could be due to a procedural/user event but the screws remained implanted so were not available to be returned for testing. Since the embedded screw is comprised of bio-compatible material, migration is not likely since the screw is contained within the bone as the single image x-ray shows. The impact to the patient beyond the retained implantable screw cannot be determined. No further clinical/medical assessment is warranted at this time. 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 for the listed part did not reveal additional complaints for the listed batch. Without the actual product involved our investigation cannot proceed. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary. If the devices are received in the future, this complaint can be re-opened. We consider this complaint closed.
 
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Brand NameR3 3 HOLE ACET SHELL MM48
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8044712
MDR Text Key126355418
Report Number1020279-2018-02415
Device Sequence Number1
Product Code MBL
UDI-Device Identifier03596010598226
UDI-Public03596010598226
Combination Product (y/n)N
PMA/PMN Number
K070756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71335548
Device Lot Number17LM17003
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

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