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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DISTAL FEMORAL IMPACTOR; HIP INSTRUMENTS : IMPACTORS
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DEPUY ORTHOPAEDICS INC US LPS DISTAL FEMORAL IMPACTOR; HIP INSTRUMENTS : IMPACTORS Back to Search Results
Model Number 2987-70-003
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/23/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that prior to surgery the spring portion of the handle was missing from the handle.
 
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Brand Name
LPS DISTAL FEMORAL IMPACTOR
Common Device Name
HIP INSTRUMENTS : IMPACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12173229
Report Number1818910-2021-15257
Device Sequence Number935373
Product Code HWA
UDI-Device Identifier10603295158813
UDI-Public10603295158813
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/13/2021
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 Model Number2987-70-003
Device Catalogue Number298770003
Device Lot NumberA0905
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/23/2021
Supplement Date Received by Manufacturer07/19/2021
Initial Report FDA Received Date07/15/2021
Supplement Report FDA Received Date07/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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