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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP IMPACTOR; HIP INSTRUMENT : IMPACTOR
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DEPUY ORTHOPAEDICS INC US UNK HIP IMPACTOR; HIP INSTRUMENT : IMPACTOR Back to Search Results
Catalog Number UNK HIP IMPACTOR
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
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 the impactor was scratched during the case and could potentially harm a poly liner upon impaction.
 
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.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 HIP IMPACTOR
Type of Device
HIP INSTRUMENT : IMPACTOR
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11816307
MDR Text Key250337009
Report Number1818910-2021-10163
Device Sequence Number1
Product Code HWA
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 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP IMPACTOR
Was Device Available for Evaluation? No
Date Manufacturer Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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