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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*NRH REPL HINGE PIN/XSM/SM BONE SCREWS AND PINS : KNEE TIBIAL INSERT ACCESSORY

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DEPUY ORTHOPAEDICS INC US SROM*NRH REPL HINGE PIN/XSM/SM BONE SCREWS AND PINS : KNEE TIBIAL INSERT ACCESSORY Back to Search Results
Catalog Number 621640
Device Problems Adverse Event Without Identified Device or Use Problem; Appropriate Term/Code Not Available
Event Date 08/22/2019
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

Revision of s-rom noiles rotating hinge inlay right side as patient suffered pain and instability. Date of initial surgery: 2016, date of revision: (b)(6) 2019. Surgeon found the inlay`s pe-ring (see picture) worn. A surgical delay was not reported.

 
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Type of DeviceBONE SCREWS AND PINS : KNEE TIBIAL INSERT ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , IN 19380-0988
6103142063
MDR Report Key9088209
Report Number1818910-2019-105477
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 08/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number621640
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated By Manufacturer? No
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: 09/19/2019 Patient Sequence Number: 1
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