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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,30NK 14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,30NK 14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Model Number 52-3291
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Nonunion/Delayed-union Bone Fracture (2369)
Date of Event 03/01/2021
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
The patient was revised due to a non union of her femoral osteotomy (which was plated during the previous surgery).The stem and head were extracted and a long stem was implanted to help reduce fx with a new trauma late/screws.We trialed the head and implanted the real head once it was decided to be the correct size.No surgical delay.Doi: (b)(6) 2020, dor: (b)(6) 2021, right hip.
 
Additional 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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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 Key11527217
Report Number1818910-2021-05547
Device Sequence Number14577281
Product Code JDI
UDI-Device Identifier10603295170969
UDI-Public10603295170969
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
P070026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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,Followup
Report Date (Section B) 03/01/2021
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? No
Operator of Device Health Professional
Device Model Number52-3291
Device Catalogue Number523291
Device Lot Number8896057
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/01/2021
Supplement Date Received by Manufacturer04/09/2021
Initial Report FDA Received Date03/19/2021
Supplement Report FDA Received Date04/11/2021
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
DELTA CER HEAD 11/13 28MM +0; S-ROM*STM STD,30NK 14X09X130; UNK HIP FEMORAL SLEEVE SROM; DELTA CER HEAD 11/13 28MM +0; S-ROM*STM STD,30NK 14X09X130; UNK HIP FEMORAL SLEEVE SROM
Outcome Attributed to Adverse Event Required Intervention;
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