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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 40X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 40X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-40-000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Anemia (1706); Edema (1820); Hematoma (1884); Pain (1994); Seroma (2069); Joint Dislocation (2374); No Code Available (3191)
Event Date 12/09/2019
Event Type  Injury  
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
Patient received implant unknown hip side on (b)(6) 2019.Revision on (b)(6) 2019 because of pain and luxation.The pe ring was found to be fractured.Further details unknown at the moment.
 
Manufacturer Narrative
Product complaint # (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  patient code: no code available (3191) used to capture device revision or replacement.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : following review of the information received, it was concluded that it was unlikely that a product issue as a result of the manufacture or design was present.The complaint shall be closed with an unjustified conclusion, it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  additional narrative:.
 
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Brand Name
SELF CENT HIP 40X28 RUST
Type of Device
HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9557504
MDR Text Key173934201
Report Number1818910-2020-00769
Device Sequence Number1
Product Code KWY
UDI-Device Identifier10603295003304
UDI-Public10603295003304
Combination Product (y/n)N
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1035-40-000
Device Catalogue Number103540000
Device Lot NumberJ4339Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Date Manufacturer Received03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALTRX +4 NEUT 40IDX60OD; ARTICUL/EZE BALL 28 +8.5 BL; ALTRX +4 NEUT 40IDX60OD; ARTICUL/EZE BALL 28 +8.5 BL
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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