MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 40IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-40-458
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, patient received a right hip revision.On (b)(6) 2018, patient presented at er with pain, stiffness, and instability secondary to a right hip dislocation after bending over and feeling a popping sensation.The dislocation was treated with a closed reduction.The procedure was completed without complications.On (b)(6) 2018, clinic note indicates the patient experienced a second dislocation of the right hip after trying to manually adduct the right leg while sitting.The dislocation was again treated with a closed reduction.The procedure was completed without complications.This dislocation and treatment is a continuation of the previous dislocation dated (b)(6), 2018.Clinic notes dated (b)(6) 2018, (b)(6) 2018, (b)(6) 2018, and (b)(6) 2018: follow-up visits s/p dislocation x 2 following right hip tha revision.Radiographs identify a well-fixed and appropriately aligned right tha.The patient sees improvement in pain, function, and participation in adls.Doi: (b)(6) 2018.Doe: (b)(6) 2018 and (b)(6) 2018: dislocation treated with closed reduction.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.Component code: appropriate term/code not available ((b)(4)) used to capture no findings available.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.

• Brand Name: ALTRX +4 NEUT 40IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15924108
• Report Number: 1818910-2022-24390
• Device Sequence Number: 5258682
• Product Code: LPH
• UDI-Device Identifier: 10603295016601
• UDI-Public: 10603295016601
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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: 1221-40-458
• Device Catalogue Number: 122140458
• Device Lot Number: 658105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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: CORAIL2 LAT COXA VARA SIZE 13.; DLT TS CER HD 12/14 40MM +8.5.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN CAN BONE SCREW 6.5MMX45MM.; PINN MULTIHOLE W/GRIPTION 58MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White