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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 5.5X60MM GRIPTION TF STE SCREW GRIPTION TF AUGMENT : HIP METAL ACETABULAR CUPS

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DEPUY IRELAND - 9616671 5.5X60MM GRIPTION TF STE SCREW GRIPTION TF AUGMENT : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-60-800
Device Problem Loss of Osseointegration
Event Date 06/02/2020
Event Type  Injury  
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 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.

 
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Brand Name5.5X60MM GRIPTION TF STE SCREW
Type of DeviceGRIPTION TF AUGMENT : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw , IN 46581-0988
6107428552
MDR Report Key10145687
Report Number1818910-2020-13687
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1217-60-800
Device Catalogue Number121760800
Device LOT Number467531
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/06/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/11/2020 Patient Sequence Number: 1
Treatment
5.5X45MM 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 GRIP TF REV AUGM 15X50/52
PINN MULTIHOLE W/GRIPTION 50MM
PINNACLE BONE SCREW 25 MM
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