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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-31-048
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/09/2020
Type of Reportable Event Malfunction
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
After cup was impacted into the acetabulum, the surgeon asked for an apex hole eliminator.He inserted the hole eliminator into the cup and it went straight through the hole in the cup, and fell off the screwdriver behind the new acetabular cup.After telling me what had happened, he continued surgery as normal.There was a slight surgical delay.No additional information is available.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
 
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Brand Name
PINN 100 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 Key10875872
Report Number1818910-2020-25109
Device Sequence Number2636072
Product Code JDI
UDI-Device Identifier10603295010180
UDI-Public10603295010180
Combination Product (Y/N)N
Initial Reporter CountryEI
PMA/510(K) Number
K090998
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1217-31-048
Device Catalogue Number121731048
Device Lot Number9590062
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/09/2020
Supplement Date Received by Manufacturer11/09/2020
01/21/2021
Initial Report FDA Received Date11/20/2020
Supplement Report FDA Received Date11/20/2020
01/22/2021
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
APEX HOLE ELIM POSITIVE STOP; PINN 100 W/GRIPTION 48MM; APEX HOLE ELIM POSITIVE STOP; PINN 100 W/GRIPTION 48MM
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