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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 36MM +9; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 36MM +9; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-36-240
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 09/28/2020
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
The patient was revised for infection.All implants removed except for the proximal sleeve.Original implant date unknown.No surgical delay.Doi: unknown; dor: (b)(6) 2020; left hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A photograph of the explanted femoral head has been provided and reviewed.It was not possible to determine the depuy distribution lot code and does not aid in this investigation for an allegation of infection.The information received will be retained for potential series investigations if triggered by trend analysis 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.
 
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Brand Name
DELTA CER HEAD 11/13 36MM +9
Common Device Name
S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10677826
Report Number1818910-2020-22280
Device Sequence Number3105494
Product Code LZO
UDI-Device Identifier10603295033592
UDI-Public10603295033592
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K062748
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/28/2020
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 Number1365-36-240
Device Catalogue Number136536240
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/28/2020
Supplement Date Received by Manufacturer11/12/2020
Initial Report FDA Received Date10/14/2020
Supplement Report FDA Received Date11/13/2020
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
ALTRX +4 NEUT 36IDX58OD; PINNACLE SECTOR II CUP 58MM; SROM*STM ST,36+8L NK,20X15X165; UNKNOWN HIP FEMORAL SROM PROXIMAL SLEEVE; ALTRX +4 NEUT 36IDX58OD; PINNACLE SECTOR II CUP 58MM; SROM*STM ST,36+8L NK,20X15X165; UNKNOWN HIP FEMORAL SROM PROXIMAL SLEEVE
Outcome Attributed to Adverse Event Required Intervention;
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