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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-34-000
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 06/01/2021
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 that the patient presented with a painful total hip, surgeon elected to revise the cup to a competitor and exchange the head.Doi: (b)(6) 2009; dor: (b)(6) 2021; affected side: left 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: for allegations of pain a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.
 
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Brand Name
S-ROM M HEAD 36MM +9
Common Device Name
S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12009036
Report Number1818910-2021-12774
Device Sequence Number3426587
Product Code LPH
UDI-Device Identifier10603295033523
UDI-Public10603295033523
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K120599
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
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) 06/01/2021
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 Number1365-34-000
Device Catalogue Number136534000
Device Lot Number2569141
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/01/2021
Supplement Date Received by Manufacturer07/13/2021
Initial Report FDA Received Date06/16/2021
Supplement Report FDA Received Date07/15/2021
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 6.5MMX40MM; PINN MULTIHOLE W/GRIPTION 50MM; PINNACLE MTL INS NEUT36IDX50OD; S-ROM M HEAD 36MM +9; PINN CAN BONE SCREW 6.5MMX40MM; PINN MULTIHOLE W/GRIPTION 50MM; PINNACLE MTL INS NEUT36IDX50OD; S-ROM M HEAD 36MM +9
Outcome Attributed to Adverse Event Required Intervention;
Patient Age51 YR
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