MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 32 +5 BR; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-22-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Seroma (2069); No Code Available (3191)

Event Date 05/17/2020

Event Type  Injury  

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 Description

Infected hip, originally done on the (b)(6) 2020.Massive seroma found when re entering the hip, patient washed out and the liner and head where removed and replaced with new implants.Doi: (b)(6) 2020.Dor: (b)(6) 2020; right hip.

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.

• Brand Name: ARTICUL/EZE BALL 32 +5 BR
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10105907
• MDR Text Key: 193085734
• Report Number: 1818910-2020-12932
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033189
• UDI-Public: 10603295033189
• Combination Product (y/n): N
• PMA/PMN Number: K843909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1365-22-000
• Device Catalogue Number: 136522000
• Device Lot Number: D19110925
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 32 +5 BR; PINN MAR LIP LNR 32IDX58OD; ARTICUL/EZE BALL 32 +5 BR; PINN MAR LIP LNR 32IDX58OD
• Patient Outcome(s): Required Intervention