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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 +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-31-000
Medical Device Problem Codes Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 07/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Pinnacle unf and medical records received.After review of the medical records the patient was revised due to malfunction of mom left hip arthroplasty resulting to pain, elevated cobalt and chromium level and mechanical sensation left tha.Operative note reported milky yellow fluid collection consistent with adverse local tissue reaction with dark staining of the capsular tissues and synovium.Noticeable gross wear of the superior aspect of the acetabular liner.Significant corrosion noted at the locking mechanism of the liner and the shell.However, minimal corrosion noted at the head neck taper junction.Doi: (b)(6) 2008; dor: (b)(6) 2019; 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 : a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.
 
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Brand Name
S-ROM M HEAD 36MM +0
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 Key11731547
Report Number1818910-2021-08841
Device Sequence Number14350390
Product Code LPH
UDI-Device Identifier10603295033363
UDI-Public10603295033363
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K120599
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/13/2021
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 Expiration Date02/28/2013
Device Model Number1365-31-000
Device Catalogue Number136531000
Device Lot Number2552681
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/13/2021
Supplement Date Received by Manufacturer05/25/2021
Initial Report FDA Received Date04/27/2021
Supplement Report FDA Received Date05/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM; S-ROM M HEAD 36MM +0; S-ROM*SLEEVE PRX ZTT, 16B-SML; S-ROM*STM STD,36NK,16X11X150; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM; S-ROM M HEAD 36MM +0; S-ROM*SLEEVE PRX ZTT, 16B-SML; S-ROM*STM STD,36NK,16X11X150
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
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