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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER DOME 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. REAMER DOME 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Catalog Number 71362752
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/07/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during surgery, while reaming the acetabulum, it was discovered that the reamer had become dull.Also, device broke over the patient incision, there was no harm to the patient, no pieces were left in the patient, procedure continued without delay using another size.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
 
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Brand Name
REAMER DOME 52MM
Common Device Name
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8663102
Report Number1020279-2019-02156
Device Sequence Number284640
Product Code JDH
UDI-Device Identifier03596010456908
UDI-Public03596010456908
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number71362752
Initial Date Received by Manufacturer 05/10/2019
Supplement Date Received by Manufacturer05/10/2019
Initial Report FDA Received Date06/03/2019
Supplement Report FDA Received Date10/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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