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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-01-056
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888)
Event Date 10/01/2020
Event Type  Death  
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 Description
Clinical adverse event received for death, secondary to possible gastrointestinal bleed.Event serious and is considered severe/fatal.Event is definitely not related to device and is remote possibility related to procedure.Date of implantation: (b)(6) 2014.Date of revision (non-study hip): (b)(6) 2020.Date of event (onset): (b)(6) 2020 (day unknown) (right hip).Treatment: none.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A review of the provided x-ray images finds no indication of a product problem.As indicated by the complainant the report is not suspected to be device related.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.
 
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Brand Name
PINNACLE 100 ACET CUP 56MM
Type of Device
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10838550
MDR Text Key216204090
Report Number1818910-2020-24631
Device Sequence Number1
Product Code JDI
UDI-Device Identifier10603295008576
UDI-Public10603295008576
Combination Product (y/n)N
PMA/PMN Number
K012364
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1217-01-056
Device Catalogue Number121701056
Device Lot Number474857
Was Device Available for Evaluation? No
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
11/13 S-ROM 40MM M SPEC+9; ALTRX +4 NEUT 40IDX56OD; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 56MM; S-ROM*SLEEVE PRX ZTT, 20F-SML; SROM*STM ST,36+8L NK,20X15X165; 11/13 S-ROM 40MM M SPEC+9; ALTRX +4 NEUT 40IDX56OD; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 56MM; S-ROM*SLEEVE PRX ZTT, 20F-SML; SROM*STM ST,36+8L NK,20X15X165
Patient Outcome(s) Death;
Patient Age61 YR
Patient Weight102
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