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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-20-056
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 07/17/2020
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
It was reported that the patient had right total hip in 2017, unknown date/hospital/surgeon.It was done in a different geographic location.Patient complain of hip pain.Doi: 2017, dor: (b)(6) 2020, right side.
 
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.
 
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Brand Name
PINNACLE MULTIHOLE II CUP 56MM
Common Device Name
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10332976
Report Number1818910-2020-16986
Device Sequence Number859377
Product Code KWA
UDI-Device Identifier10603295009641
UDI-Public10603295009641
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K073504
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) 07/17/2020
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? Yes
Operator of Device Health Professional
Device Model Number1217-20-056
Device Catalogue Number121720056
Device Lot NumberFF2CR1
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/17/2020
Supplement Date Received by Manufacturer09/08/2020
Initial Report FDA Received Date07/28/2020
Supplement Report FDA Received Date09/08/2020
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
12/14 ARTICUL 40MM M SPEC-2; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT40IDX56OD; 12/14 ARTICUL 40MM M SPEC-2; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT40IDX56OD
Outcome Attributed to Adverse Event Required Intervention;
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