MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 PINNACLE DM LINER 50_43; TOTAL HIP JOINT REPLACEMENT PROSTHESIS

Model Number	1218-50-043
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.
Event or Problem Description
Patient underwent primary right thr on (b)(6) 2009 where a corail stem with a mom pinnacle liner articulation was utilized, due to the patients young age.Pinnacle mom liner was removed and pinnacle dual mobility liner implanted.A new 22mm head was implanted (shell and stem left in situ) revision reported patient has subsequently dislocated 3x and has been reduced.A decision was made to open the hip and identify the issue.On opening the hip the hip was ranged through a rom to determine cause of dislocation (the hip was difficult to dislocate and required an extreme rom to do so).Dr liu elected to remove the pinnacle shell and liner along with the dual mobility head and replace the cup with a zm cup and one of their dual mobility liners.Doi: (b)(6) 2022; dor: (b)(6) 2023; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE DM LINER 50_43
• Common Device Name: TOTAL HIP JOINT REPLACEMENT PROSTHESIS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16522542
• Report Number: 1818910-2023-05572
• Device Sequence Number: 17770904
• Product Code: LPH
• UDI-Device Identifier: 10603295520184
• UDI-Public: 10603295520184
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2023

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
• Device Model Number: 1218-50-043
• Device Catalogue Number: 121850043
• Device Lot Number: 9832878
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 05/09/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 03/21/2023; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 22.225+4 NK; BI MENTUM PFR PE LINER 4322; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR HA ACET CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female