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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-12-048
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/26/2020
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
Operation date (b)(6) 2020 by dr (b)(6) at (b)(6).Revision of actetabular components from a patient who had a primary hip on the (b)(6)2018 by dr (b)(6) at (b)(6).Primary original stem was not removed in this revision on the head, cup, liner, screws and insert.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.H10 additional narrative:  corrected: h6 (device).
 
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Brand Name
PINN SECTOR HA ACET CUP 48MM
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 Key10251610
Report Number1818910-2020-15391
Device Sequence Number16261056
Product Code LPH
UDI-Device Identifier10603295009146
UDI-Public10603295009146
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K031495
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/26/2020
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 Number1217-12-048
Device Catalogue Number121712048
Device Lot NumberHK1088
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/26/2020
Supplement Date Received by Manufacturer07/29/2020
Initial Report FDA Received Date07/09/2020
Supplement Report FDA Received Date07/30/2020
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
DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR +4 10D 32IDX48OD; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR +4 10D 32IDX48OD
Outcome Attributed to Adverse Event Required Intervention;
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