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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. REF THREE HOLE SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71336448
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Codes Failure of Implant (1924); Injury (2348)
Date of Event 11/15/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient underwent revision surgery due to dislocation.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.Investigation results: the associated complaint devices were not returned.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 on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A clinical analysis indicates that based on the provided information, the inability to adhere to activity restrictions secondary to a mental disorder was the cause of the dislocation which contributed to the revision procedure.The patient impact beyond the revision itself cannot be concluded.No further medical assessment is warranted at this time.If the device or new information is received in the future, this complaint can be re opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
REF THREE HOLE SHELL 48MM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7047971
Report Number1020279-2017-01076
Device Sequence Number1798744
Product Code MBL
UDI-Device Identifier03596010454331
UDI-Public03596010454331
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K960094
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date (Section B) 04/02/2018
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
Operator of Device Health Professional
Device Expiration Date03/11/2022
Device Catalogue Number71336448
Device Lot Number12CM08245
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/16/2017
Supplement Date Received by Manufacturer11/16/2017
11/16/2017
11/16/2017
Initial Report FDA Received Date11/21/2017
Supplement Report FDA Received Date11/24/2017
03/08/2018
04/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
REF XLPE 28 20 DEG 46-48 D/(B)(4)/UNKNOWN
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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