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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI 12/14 TPR SLV + 0 PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

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SMITH & NEPHEW, INC. TANDEM UNI 12/14 TPR SLV + 0 PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL Back to Search Results
Model Number 71326600
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); Fluid Discharge (2686)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after a left hip hemiarthroplasty performed on (b)(6) 2020, patient's primary wound failed to heal, with ongoing discharge from wound. Patient had revision washout and head exchange for infection on (b)(6) 2020. Implants are not available since they were sent for pathology testing. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameTANDEM UNI 12/14 TPR SLV + 0
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
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 Key11010876
MDR Text Key221498349
Report Number1020279-2020-07445
Device Sequence Number1
Product Code LZY
UDI-Device Identifier03596010196545
UDI-Public03596010196545
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K896580
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 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71326600
Device Catalogue Number71326600
Device Lot Number20FM01788
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 Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2020
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: 12/15/2020 Patient Sequence Number: 1
Treatment
CPCS COCR PRIM SO 12/14 SZ 3; CPCS DIST CENT SZ 12MM
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