MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 32 +1 GR; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-21-000

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

Patient Problems Fall (1848); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2021

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

Total hip revision - corail/pinnacle construct removed.Primary procedure conducted via daa on 13/07/2018 via daa for diagnosis of oa.Patient reported pain/discomfort 2 years + post op.According to hcp, clinical presentation on x-ray over time consistent with either infection or subsidence/aseptic loosening but no diagnosis of either.Several tests conducted between feb 2021 - aug 2021, no clear indication of infection but results could not rule out it out as diagnosis.Surgeon opted for 2 stage full hip revision.On x-ray a more radiopaque portion was identified/questioned by hcp in the threated inserter portal of the corail stem.Doi: (b)(6) 2018, dor: (b)(6) 2021, unknown side.

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 related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ARTICUL/EZE BALL 32 +1 GR
• 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: 12370503
• MDR Text Key: 268238199
• Report Number: 1818910-2021-18717
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033172
• UDI-Public: 10603295033172
• 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: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-21-000
• Device Catalogue Number: 136521000
• Device Lot Number: D18033899
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP.; ARTICUL/EZE BALL 32 +1 GR.; CORAIL2 LAT COXA VARA SIZE 10.; PINN CAN BONE SCREW 6.5MMX35MM.; PINN CAN BONE SCREW 6.5MMX35MM.; PINN MAR NEUT 32IDX52OD.; PINNACLE SECTOR II CUP 52MM.; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +1 GR; CORAIL2 LAT COXA VARA SIZE 10; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN MAR NEUT 32IDX52OD; PINNACLE SECTOR II CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR