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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN TRL LNR LIPPED 52ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

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DEPUY ORTHOPAEDICS INC US PINN TRL LNR LIPPED 52ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS Back to Search Results
Model Number 2218-32-252
Device Problems Contamination /Decontamination Problem (2895); Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
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
The liner trials are damaged.221832052 is broken on the rim as well as missing the connecting screw.221832252 is scratch and harder to clean.
 
Manufacturer Narrative
Product complaint # : pc-(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Brand Name
PINN TRL LNR LIPPED 52ODX32ID
Type of Device
HIP INSTRUMENTS : ACETABULAR TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11012953
MDR Text Key223621194
Report Number1818910-2020-27003
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295100928
UDI-Public10603295100928
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,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2218-32-252
Device Catalogue Number221832252
Device Lot NumberCY0804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2020
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received12/30/2020
02/02/2021
Supplement Dates FDA Received01/12/2021
02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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