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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HANDLE; HANDLES
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DEPUY ORTHOPAEDICS INC US UNK HANDLE; HANDLES Back to Search Results
Catalog Number UNK HANDLE
Device Problem Device-Device Incompatibility (2919)
Patient Problem Insufficient Information (4580)
Event Date 05/27/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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 on (b)(6) 2021, the patient underwent tha with the offset handle and the cup in question.During the surgery, when the surgeon drove in the cup, the offset handle and cup could not be removed.The surgery was completed successfully and there was 20 min surgical delay.No further information is available.
 
Manufacturer Narrative
Product complaint # (b)(4).Mrn 1818910-2021-12314 is retracted as depuy synthes is not the legal manufacturer of the device and was submitted in error.Med watch 3500a initial report mwr-(b)(4) , mrn 1818910-2021-12314 is retracted.
 
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Brand Name
UNK HANDLE
Type of Device
HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11974242
MDR Text Key255363203
Report Number1818910-2021-12314
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HANDLE
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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