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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CALCAR PLANER SML; REAMERS

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DEPUY ORTHOPAEDICS INC US MODULAR CALCAR PLANER SML; REAMERS Back to Search Results
Model Number 2570-04-501
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Not Applicable (3189); No Code Available (3191)
Event Date 09/15/2020
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
It was reported that patient had left anterior approach total hip surgery on (b)(6) 2020.During the procedure, the doctor accidentally broke the proximal femur.He treated the fracture with cables and inserted a longer hip stem.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
MODULAR CALCAR PLANER SML
Type of Device
REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10594628
MDR Text Key208819081
Report Number1818910-2020-21014
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10603295482024
UDI-Public10603295482024
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2570-04-501
Device Catalogue Number257004501
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN CABLE WIRES; UNKNOWN HIP FEMORAL STEM; UNKNOWN CABLE WIRES; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age86 YR
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