MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN REVISION W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-16-054
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was revised to address migration and loosening of the cup at the bone to implant interface.Cancer patient.Converted to tri-flange.Proximal femur and segment removed to re-establish leg length.Doi: (b)(6) 2018, dor: (b)(6) 2021 affected side: left hip.
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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN REVISION W/GRIPTION 54MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12646632
• Report Number: 1818910-2021-22843
• Device Sequence Number: 19260641
• Product Code: JDI
• UDI-Device Identifier: 10603295009313
• UDI-Public: 10603295009313
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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 Number: 1217-16-054
• Device Catalogue Number: 121716054
• Device Lot Number: J22Y90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM DIA TPRD HD PER SCRW 55; 5.0MM DIA TPRD HD PER SCRW 55; DELTA CER HEAD 12/14 28MM +1.5; LPS PROX FEM STD BODY 15DEG LT; LPS SEGMENTAL COMPONENT 85MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN CAN BONE SCREW 6.5MMX50MM; PINN CAN BONE SCREW 6.5MMX55MM; PINN LNR CON +4 NEUT 28IDX48OD; PINN REVISION W/GRIPTION 54MM; 5.0MM DIA TPRD HD PER SCRW 55; 5.0MM DIA TPRD HD PER SCRW 55; DELTA CER HEAD 12/14 28MM +1.5; LPS PROX FEM STD BODY 15DEG LT; LPS SEGMENTAL COMPONENT 85MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN CAN BONE SCREW 6.5MMX50MM; PINN CAN BONE SCREW 6.5MMX55MM; PINN LNR CON +4 NEUT 28IDX48OD; PINN REVISION W/GRIPTION 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female