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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX60MM; BONE SCREWS AND PINS : SCREWS
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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX60MM; BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 121760500
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 05/10/2006
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).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.(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
Litigation alleges loosening of cup.
 
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Brand Name
PINN CAN BONE SCREW 6.5MMX60MM
Common Device Name
BONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8066496
Report Number1818910-2018-75347
Device Sequence Number950206
Product Code LPH
UDI-Device Identifier10603295010432
UDI-Public10603295010432
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K983014
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2006
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/23/2018
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? No
Operator of Device Health Professional
Device Catalogue Number121760500
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/23/2018
Initial Report FDA Received Date11/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
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