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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S-ROM*ADAPTOR HUDSON TO ZIMMER; HIP INSTRUMENTS : ADAPTORS
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S-ROM*ADAPTOR HUDSON TO ZIMMER; HIP INSTRUMENTS : ADAPTORS Back to Search Results
Model Number 53-0302
Device Problems Crack (1135); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2021
Event Type  malfunction  
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
Compass case (b)(4) reports: it was reported that the 2 "wings" ,where the instrument attaches to the srom adapter, cracked and will no longer securely hold an instrument.No surgical delay reported.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received for examination.Therefore, the reported event could not be confirmed.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Type of Device
HIP INSTRUMENTS : ADAPTORS
MDR Report Key12433421
MDR Text Key271071608
Report Number1818910-2021-19407
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10603295171539
UDI-Public10603295171539
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 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number53-0302
Device Catalogue Number530302
Device Lot NumberSO2042917
Was Device Available for Evaluation? No
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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