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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM BONE SCREWS AND PINS : SCREWS

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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM BONE SCREWS AND PINS : SCREWS Back to Search Results
Model Number 1217-35-500
Device Problems Loss of Osseointegration; Osseointegration Problem
Event Date 12/23/2005
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Pinncale claim submission form and medical records received. After review of medical records, it was stated that the patient was revised to address pain and loosening. There was evidence of lucency in the acetabular cup. Revision notes reported a loose acetabulum. All depuy devices were explanted except for the srom sleeve. Doi: (b)(6) 2005; dor: (b)(6) 2005; right hip.

 
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Brand NamePINN CAN BONE SCREW 6.5MMX35MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE RAYNHAM MFG SITE
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key9776465
Report Number1818910-2020-06561
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1217-35-500
Device Catalogue Number121735500
Device LOT NumberY5RJC4000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/05/2004
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: 03/02/2020 Patient Sequence Number: 1
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