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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMORAL COCR 28+12; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMORAL COCR 28+12; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 52-2030
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Wound Dehiscence (1154); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Fluid Discharge (2686); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event 04/30/2021
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
On (b)(6) 2020, the patient had a revision of left total hip arthroplasty to address wound breakdown with hematoma and drainage, recurrent instability with dislocation, and coagulopathy.The indications for surgery included that the patient had a revision 6 weeks prior (captured in (b)(4)) to address a failed constrained liner and medical records indicated the patient was having pain.The patient dislocated after that surgery and needed a reduction.During this current procedure the acetabular and femoral components were revised.The surgeon reported finding a complete failure of the posterior soft tissue, and really no longer any soft tissues present to repair.There was a small amount of hematoma.He was coagulopathic during the case.
 
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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
 
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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 Key11871920
Report Number1818910-2021-11021
Device Sequence Number861089
Product Code JDI
UDI-Device Identifier10603295170815
UDI-Public10603295170815
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K920317
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/05/2021
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 Number52-2030
Device Catalogue Number522030
Device Lot Number8524916
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/05/2021
Supplement Date Received by Manufacturer08/16/2021
Initial Report FDA Received Date05/24/2021
Supplement Report FDA Received Date08/18/2021
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
APEX HOLE ELIM POSITIVE STOP.; BI MENTUM PFRK PE LINER 28 53.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINNACLE DM LINER 64_53.; PINNACLE SECTOR II CUP 64MM.; S-ROM*SLEEVE PRX ZTT, 20F-LRG.; SROM STM STD 36+12L 15X20.; APEX HOLE ELIM POSITIVE STOP; BI MENTUM PFRK PE LINER 28 53; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE DM LINER 64_53; PINNACLE SECTOR II CUP 64MM; S-ROM*SLEEVE PRX ZTT, 20F-LRG; SROM STM STD 36+12L 15X20
Outcome Attributed to Adverse Event Required Intervention;
Patient Age69 YR
Patient Weight88
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