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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,42 NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,42 NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Model Number 52-3393
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646)
Date of Event 08/04/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Patient was revised due to painful left hip and loosening of the stem at bone to implant interface.Doi: (b)(6) 2003, dor: (b)(6) 2021, left hip.
 
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Common Device Name
S-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12555076
Report Number1818910-2021-21582
Device Sequence Number14450682
Product Code JDI
UDI-Device Identifier10603295170990
UDI-Public10603295170990
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P070026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/04/2021
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? Yes
Operator of Device Health Professional
Device Model Number52-3393
Device Catalogue Number523393
Device Lot Number946886
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/04/2021
Initial Report FDA Received Date09/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR NEUT 32IDX62OD; S-ROM*HEAD FEMORAL COCR 32+0; S-ROM*SLEEVE PRX ZTT, 18F-LRG; S-ROM*STM STD,42 NK,18X13X160; UNKNOWN HIP ACETABULAR CUP
Outcome Attributed to Adverse Event Required Intervention;
Patient Age67 YR
Patient Weight91
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