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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18F-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
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DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18F-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Model Number 55-0526
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 02/02/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported as prostalac due to infection.Srom and competitors cup construct removed and replaced with a prostalac.Doi: (b)(6) 2020, dor: (b)(6) 2021, affected side: right hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : 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, sterile processing 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 SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11342560
Report Number1818910-2021-03223
Device Sequence Number3737350
Product Code LPH
UDI-Device Identifier10603295175315
UDI-Public10603295175315
Combination Product (Y/N)N
Initial Reporter StateNC
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) 02/02/2021
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 Number55-0526
Device Catalogue Number550526
Device Lot Number9514486
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/02/2021
Supplement Date Received by Manufacturer03/17/2021
Initial Report FDA Received Date02/18/2021
Supplement Report FDA Received Date03/19/2021
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
COMPETITOR CUP; COMPETITOR LINER; DELTA CER HEAD 11/13 28MM +3; S-ROM*SLEEVE PRX ZTT, 18F-LRG; SROM*STM ST,36+8L NK,18X13X160; COMPETITOR CUP; COMPETITOR LINER; DELTA CER HEAD 11/13 28MM +3; S-ROM*SLEEVE PRX ZTT, 18F-LRG; SROM*STM ST,36+8L NK,18X13X160
Outcome Attributed to Adverse Event Required Intervention;
Patient Age76 YR
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