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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM M HEAD 36MM -3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM M HEAD 36MM -3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 136526000
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Codes Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Test Result (2695)
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
Ppf and implant records received.Ppf alleges pseudotumor, metal wear, metallosis and elevated metal ions.Liner was non depuy.Doi: (b)(6) 2013 - dor: none reported (right hip).
 
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
S-ROM M HEAD 36MM -3
Common Device Name
S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8920970
Report Number1818910-2019-101968
Device Sequence Number268937
Product Code JDI
UDI-Device Identifier10603295033226
UDI-Public10603295033226
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K120599
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/01/2019
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 Catalogue Number136526000
Device Lot Number3605155
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/01/2019
Supplement Date Received by Manufacturer08/23/2019
Initial Report FDA Received Date08/22/2019
Supplement Report FDA Received Date08/26/2019
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
UNKNOWN HIP ACETABULAR LINERS
Outcome Attributed to Adverse Event Required Intervention;
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