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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 17X22; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 17X22; S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Model Number 56-3622
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 11/05/2020
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
The patient was revised due to infected hip; surgeon explanted components and implanted prostalac spacer.Doi: (b)(6) 2020, dor: (b)(6) 2020, left hip.
 
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, sterilization 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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Brand Name
SROM STM STD 36+12L 17X22
Type of Device
S-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10853707
MDR Text Key216668243
Report Number1818910-2020-24832
Device Sequence Number1
Product Code MRA
UDI-Device Identifier10603295178248
UDI-Public10603295178248
Combination Product (y/n)N
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number56-3622
Device Catalogue Number563622
Device Lot Number9410440
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
11/13 S-ROM 40MM M SPEC+12; ALTRX +4 NEUT 40IDX66OD; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN MULTIHOLE W/GRIPTION 66MM; S-ROM*SLEEVE PRX ZTT, 22D-SML; SROM STM STD 36+12L 17X22; 11/13 S-ROM 40MM M SPEC+12; ALTRX +4 NEUT 40IDX66OD; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN MULTIHOLE W/GRIPTION 66MM; S-ROM*SLEEVE PRX ZTT, 22D-SML; SROM STM STD 36+12L 17X22
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient Weight137
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