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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 45OD 28ID PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 45OD 28ID PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 71324045
Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923); Misassembly by Users (3133)
Patient Problem Joint Dislocation (2374)
Event Date 07/11/2021
Event Type  Injury  
Event Description
It was reported that, after thr surgery had been performed with a tandem intl bipolar 45od 28id on (b)(6) 2021, in which surgeon had a hard time to click the ring in the head, the patient experienced a hip dislocation. This adverse event was solved by a revision surgery on (b)(6) 2021. The current health status of patient is unknown.
 
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Brand NameTANDEM INTL BIPOLAR 45OD 28ID
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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 Key12243755
MDR Text Key264036165
Report Number1020279-2021-06093
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71324045
Device Catalogue Number71324045
Device Lot NumberR2129410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received06/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2021
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: 07/29/2021 Patient Sequence Number: 1
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