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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS HP SPACER BLK MED/LG+; KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS
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DEPUY ORTHOPAEDICS INC US LCS HP SPACER BLK MED/LG+; KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS Back to Search Results
Catalog Number 217843015
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: this device was not returned for evaluation but based on the received photographs the complaint can be confirmed.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
The spacer block adapter connection port is not locking spacer adaptor securely.
 
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Brand Name
LCS HP SPACER BLK MED/LG+
Common Device Name
KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8084377
Report Number1818910-2018-75889
Device Sequence Number2165710
Product Code HWT
UDI-Device Identifier10603295094890
UDI-Public10603295094890
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/16/2018
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 Number217843015
Device Lot NumberH0107
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/16/2018
Initial Report FDA Received Date11/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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