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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PINN GRIP TF REV AUGM 15X50/52; GRIPTION TF AUGMENT : HIP METAL ACETABULAR CUPS
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DEPUY IRELAND - 9616671 PINN GRIP TF REV AUGM 15X50/52; GRIPTION TF AUGMENT : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-15-250
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 06/02/2020
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 was revised to address painful loosening of acetabular components and augment at bone to implant interface.Doi: (b)(6) 2015.Dor: (b)(6) 2020.Affected side: 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 GRIP TF REV AUGM 15X50/52
Common Device Name
GRIPTION TF AUGMENT : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10145646
Report Number1818910-2020-13689
Device Sequence Number3184766
Product Code JDI
UDI-Device Identifier10603295009245
UDI-Public10603295009245
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
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) 06/02/2020
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 Number1217-15-250
Device Catalogue Number121715250
Device Lot Number601542
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/02/2020
Supplement Date Received by Manufacturer07/24/2020
Initial Report FDA Received Date06/11/2020
Supplement Report FDA Received Date07/27/2020
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
5.5X45MM GRIPTION TF STE SCREW; 5.5X60MM GRIPTION TF STE SCREW; ALTRX +4 NEUT 32IDX50OD; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN MULTIHOLE W/GRIPTION 50MM; PINNACLE BONE SCREW 25 MM; 5.5X45MM GRIPTION TF STE SCREW; 5.5X60MM GRIPTION TF STE SCREW; ALTRX +4 NEUT 32IDX50OD; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN MULTIHOLE W/GRIPTION 50MM; PINNACLE BONE SCREW 25 MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
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