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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 523418
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/28/2023
Event Type  Injury  
Event Description
Patient was revised due to hip infection.The implants were explanted and an antibiotic prostalac spacer was implanted.There was no surgical delay.Doi: (b)(6) 2008 dor: (b)(6) 2023 affected side: right hip.
 
Manufacturer Narrative
Product complaint #
=
> pc-(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Type of Device
S-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key17511374
MDR Text Key320900758
Report Number1818910-2023-16606
Device Sequence Number1
Product Code MRA
UDI-Device Identifier10603295171034
UDI-Public10603295171034
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number523418
Device Lot Number2475038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/28/2023
Initial Date FDA Received08/11/2023
Supplement Dates Manufacturer Received08/24/2023
Supplement Dates FDA Received08/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ASR ACETABULAR CUPS 52; ASR UNI FEMORAL IMPL SIZE 46; S-ROM*SLEEVE PRX ZTT, 18F-LRG; UNK HIP FEMORAL SLEEVE ASR
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient SexMale
Patient Weight94 KG
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