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 Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/30/2020

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

Washout of a potential infected thr.Primary procedure was done on (b)(6) 2009.Patient presented with severe pain and discomfort.Blood showed increase with white cells and surgeon suspected an infection.No grossly contaminated infected tissue could be seen or was super obvious.Multiple specimens taken intra-op for testing.Femoral head and poly liner removed.Massive washout completed and new head and liner were inserted into right hip.

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 device was implanted approximately 11 years prior a need for revision surgery.It is not suspected any error in device manufacture or sterile processing was the root cause for the problems reported.A manufacturing records evaluation (mre) was not performed.

• 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: 11332099
• MDR Text Key: 231991291
• Report Number: 1818910-2021-03050
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033189
• UDI-Public: 10603295033189
• Combination Product (y/n): N
• PMA/PMN Number: K883460
• 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: 01/31/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 1365-22-000
• Device Catalogue Number: 136522000
• Device Lot Number: D09050374
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/15/2021
• 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 32IDX60OD; ARTICUL/EZE BALL 32 +5 BR; PINN MAR LIP LNR 32IDX60OD
• Patient Outcome(s): Required Intervention