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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC

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SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC Back to Search Results
Model Number 71332530
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cyst(s) (1800)
Event Date 12/08/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that revision surgery was scheduled to potentially remove and replace acetabular cup and liner due to suspected loosening due to lysis. Upon inspection the cup was well fixed and a cyst was found under a section of the cup. This was excised and bone graft placed through the hole in the cup. A new liner and femoral head were put in place and the wound closed. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameREF SPHER HEAD SCREW 30MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC
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 Key11095645
MDR Text Key224383008
Report Number1020279-2020-08037
Device Sequence Number1
Product Code MEH
UDI-Device Identifier03596010460479
UDI-Public03596010460479
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K990666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71332530
Device Catalogue Number71332530
Device Lot Number13JM06402
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/11/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2020 Patient Sequence Number: 1
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