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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-30-048
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 09/01/2020
Type of Reportable Event Serious Injury
Additional 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.
 
Event or Problem Description
The patient's cup was revised to address the loosening of the acetabular component.The cup construct was removed and re prepped for a larger gription multihole cup.Headsize and offset were also increased.The stem remained.I have no further information.Doi: (b)(6) 2020.Dor: (b)(6) 2020; left hip.
 
Additional 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.
 
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Brand Name
PINN MULTIHOLE W/GRIPTION 48MM
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 Key10540014
Report Number1818910-2020-20155
Device Sequence Number14230717
Product Code LPH
UDI-Device Identifier10603295009962
UDI-Public10603295009962
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K071784
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/01/2020
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 Model Number1217-30-048
Device Catalogue Number121730048
Device Lot NumberJ1704G
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/01/2020
Supplement Date Received by Manufacturer10/13/2020
Initial Report FDA Received Date09/16/2020
Supplement Report FDA Received Date10/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ALTRX +4 NEUT 32IDX48OD; PINN CAN BONE SCREW 6.5MMX20MM; PINN MULTIHOLE W/GRIPTION 48MM; PINNACLE BONE SCREW 35 MM; UNKNOWN HIP FEMORAL STEM; ALTRX +4 NEUT 32IDX48OD; PINN CAN BONE SCREW 6.5MMX20MM; PINN MULTIHOLE W/GRIPTION 48MM; PINNACLE BONE SCREW 35 MM; UNKNOWN HIP FEMORAL STEM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
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