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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 52OD 28ID PROSTHESIS HIP HEMI- FEMORAL METALPOLYMER, CEMENTED OR UNCMENTED

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SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 52OD 28ID PROSTHESIS HIP HEMI- FEMORAL METALPOLYMER, CEMENTED OR UNCMENTED Back to Search Results
Model Number 71322052
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 12/03/2018
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to a tandem shell dislocated from the stem without the head coming off the stem. Retaining ring is reported to be stuck in the shell and could not be removed. Stem remained in the patient.
 
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Brand NameTANDEM BIPOLAR COCR 52OD 28ID
Type of DevicePROSTHESIS HIP HEMI- FEMORAL METALPOLYMER, CEMENTED OR UNCMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key8205001
MDR Text Key131694896
Report Number1020279-2018-02935
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023743
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71322052
Device Catalogue Number71322052
Device Lot Number17HM07678
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2017
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: 12/28/2018 Patient Sequence Number: 1
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