MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS LNR AOX +4N 48X36; HIP IMPLANT : ACETABULAR LINER

Model Number	4722-48-436
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/01/2023
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
Clinical adverse event received for dislocation.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2023.Date of event: (b)(6) 2023.(left hip).Treatment: closed reduction/manipulation.
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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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.
Event or Problem Description
Clinical notes & operative notes received.On (b)(6) 2023 the patient had a left total hip arthroplasty to address osteoarthritis.Depuy components were implanted during this procedure.On (b)(6) 2023 medical records note the patient had was status post left anterior hip replacement with dislocation.It was noted that 6 weeks ago, the patient dislocated their hip and had a reduction.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : clinical adverse event received for dislocation.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2023, date of event: (b)(6) 2023, (left hip).Treatment: closed reduction/manipulation.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).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: EMSYS LNR AOX +4N 48X36
• Common Device Name: HIP IMPLANT : ACETABULAR LINER
• 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: 17332197
• Report Number: 1818910-2023-14440
• Device Sequence Number: 20665465
• Product Code: LPH
• UDI-Device Identifier: 10603295501077
• UDI-Public: 10603295501077
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: 4722-48-436
• Device Catalogue Number: 472248436
• Device Lot Number: 3779072
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 07/20/2023; 08/25/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/09/2023; 08/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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: ARTICULEZE M HEAD 36MM +1.5; EMSYS SHL 3HOLE 48; EMSYS STEM CLRD HO 7; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White