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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 48OD 28ID PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 48OD 28ID PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Catalog Number 71324048
Device Problem Material Erosion (1214)
Patient Problem No Code Available (3191)
Event Date 05/03/2017
Event Type  Injury  
Manufacturer Narrative
The associated complaint devices were not returned for evaluation. Please see attached for investigation results. (b)(4).
 
Manufacturer Narrative
It was communicated that explants will not be made available for investigation.
 
Event Description
It was reported that patient underwent a revision surgery due to acetabular erosion. Surgeon considers this to be not an implant failure but a failure of the patient's anatomy.
 
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Brand NameTANDEM INTL BIPOLAR 48OD 28ID
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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
markus poettker
schachenallee 29
aarau 05001
SZ   05001
MDR Report Key6603953
MDR Text Key107130401
Report Number1020279-2017-00384
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K023743
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 09/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/27/2017
Device Catalogue Number71324048
Device Lot Number07JM19266
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 Received05/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2007
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: 06/01/2017 Patient Sequence Number: 1
Treatment
COCR FEM HD GT 28OD +0, 71302800 / 12KT24773
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