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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK STEM TRIAL
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DEPUY ORTHOPAEDICS INC US UNK STEM TRIAL Back to Search Results
Catalog Number UNK STEM TRIAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Limb Fracture (4518)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (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
Primary operative notes (b)(6) 2021 indicate the patient received a left total hip replacement due to end stage osteoarthritis.During trial reduction, with trial stem in place, a small crack of the calcar was noted.Treatment included 1 intra-op cerclage wire.Final femoral stem was implanted without issue.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received for examination.Examination of the provided x-ray image confirms the reported bone fracture.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
 
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Brand Name
UNK STEM TRIAL
Type of Device
STEM TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12088962
MDR Text Key259156592
Report Number1818910-2021-13838
Device Sequence Number1
Product Code HWT
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 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK STEM TRIAL
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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