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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX20MM; BONE SCREWS AND PINS : SCREWS

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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX20MM; BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 121720500
Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)
Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646)
Event Date 05/17/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation.Represents a non-healthcare professional.
 
Event Description
Litigation alleges loosening of the cup and stem.Doi: (b)(6) 2005 - dor: (b)(6) 2011 (right hip).
 
Manufacturer Narrative
Product complaint # (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 Name
PINN CAN BONE SCREW 6.5MMX20MM
Type of Device
BONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6107428552
MDR Report Key9266561
MDR Text Key182471420
Report Number1818910-2019-108867
Device Sequence Number1
Product Code LPH
UDI-Device Identifier10603295009795
UDI-Public10603295009795
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number121720500
Device Lot NumberY1WA84000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/18/2019
Initial Date FDA Received11/01/2019
Supplement Dates Manufacturer Received12/11/2019
Supplement Dates FDA Received01/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age64 YR
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