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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 5.0MM DIA TPRD HD PER SCRW 30 BONE SCREWS AND PINS : SCREWS

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DEPUY ORTHOPAEDICS INC US 1818910 5.0MM DIA TPRD HD PER SCRW 30 BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 125730000
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Inadequate Osseointegration (2646)
Event Date 05/16/2018
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised to address loosening of the cup component at bone to implant interface. Removed cup and liner and implanted new cup. Doi: unknown; dor: (b)(6) 2018; right hip.
 
Manufacturer Narrative
Product complaint # :(b)(4). This product was reported in error. No patient death, serious injury or evidence of reportable product malfunction occurred. Depuy considers the investigation closed at this time. Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
 
Manufacturer Narrative
(b)(4). Investigation summary : no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. 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.
 
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Brand Name5.0MM DIA TPRD HD PER SCRW 30
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
in
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7673241
MDR Text Key113520174
Report Number1818910-2018-64074
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number125730000
Device Lot NumberY12MW4000
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 Received09/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2004
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: 07/10/2018 Patient Sequence Number: 1
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