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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121732062
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 12/20/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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
Ppf alleges loosening of cup, dislocation and infection after first revision (right hip).
 
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Brand Name
PINN SECTOR W/GRIPTION 62MM
Common Device Name
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8539902
Report Number1818910-2019-91350
Device Sequence Number2443662
Product Code LPH
UDI-Device Identifier10603295010357
UDI-Public10603295010357
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K071784
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2016
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/01/2019
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
Operator of Device Health Professional
Device Expiration Date12/30/2021
Device Catalogue Number121732062
Device Lot Number181963
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/01/2019
Initial Report FDA Received Date04/23/2019
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 Age66 YR
Patient Weight112
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