• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNIPOLAR 50MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. TANDEM UNIPOLAR 50MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL Back to Search Results
Model Number 126650
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)(6).
 
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.
 
Manufacturer Narrative
It was reported that after a left hip hemiarthroplasty performed on 10/18/2020, patient's primary wound failed to heal, with ongoing discharge from wound. Patient had revision washout and head exchange for infection on 11/23/2020. Implants are not available since they were sent for pathology testing. The affected complaint device, used in treatment, was not returned for evaluation. Therefore a product analysis could not be performed. Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes. A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number. The device was sterilized according to sterilization release documentation from quality control. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. A relationship, if any, between the device and the reported incident could not be corroborated. Based on this investigation, the need for corrective action is not indicated. A review of risk management files and the instructions for use found that the reported failure was documented appropriately. No medical documents were received for investigation. Therefore, no further clinical/medical; assessment is warranted at this time. Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue. With no patient medical records provided, our investigation of this report is inconclusive. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary. Should additional information be received, the complaint will be reopened. We consider this investigation closed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTANDEM UNIPOLAR 50MM
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11010948
Report Number1020279-2020-07446
Device Sequence Number1
Product Code LZY
UDI-Device Identifier03596010079794
UDI-Public03596010079794
Combination Product (y/n)N
PMA/PMN Number
K896580
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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 Number126650
Device Catalogue Number126650
Device Lot Number18LM02724
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Age56 YR
Patient Treatment(s)
CPCS COCR PRIM SO 12/14 SZ 3; CPCS DIST CENT SZ 12MM; CPCS COCR PRIM SO 12/14 SZ 3; CPCS DIST CENT SZ 12MM
Patient Outcome(s) Hospitalization; Required Intervention;
-
-