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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-31-054
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: lawyer.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
Pinnacle fact sheet and medical records received.Pfs alleges pain.After review of medical records.There was no information after 1st revision.Doi: (b)(6) 2019 - dor: none reported (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 100 W/GRIPTION 54MM
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 Key10130641
Report Number1818910-2020-13393
Device Sequence Number2143577
Product Code JDI
UDI-Device Identifier10603295010210
UDI-Public10603295010210
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K090998
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/26/2020
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? No
Operator of Device Health Professional
Device Model Number1217-31-054
Device Catalogue Number121731054
Device Lot NumberJ2958P
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/26/2020
Supplement Date Received by Manufacturer07/14/2020
Initial Report FDA Received Date06/08/2020
Supplement Report FDA Received Date07/15/2020
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 10D 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +0; PINN 100 W/GRIPTION 54MM; SROM STM STD 36+12L 13X18; ALTRX +4 10D 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 11/13 36MM +0; PINN 100 W/GRIPTION 54MM; SROM STM STD 36+12L 13X18
Outcome Attributed to Adverse Event Required Intervention;
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