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 Noise, Audible (3273)

Patient Problems Ossification (1428); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2016

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

Surgeon is reporting a disassociation of inlay from cup and heterotopic ossification.Left side affected.The patient reports hearing a ¿click¿ sound the day before yesterday and experiencing massive pain in the region of the left hip joint since that time.Radiographic follow-up shows inlay dislocation as well as brooker iv heterotopic ossification on the left.It was agreed to perform preoperative radiotherapy, removal of ossifications to the extent possible, and inlay and head replacement.During the procedure the liner was noted to have been disassociated from cup and was noted to be deformed from wear.The cup was noted to have had several small scratches of little depth on it.And was not revised.Heterotopic ossifications were noted.Doi: (b)(6) 2014, dor: (b)(6) 2016 - revision of inlay.

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 : a device manufacturing records evaluation (mre) was performed.No related deviations or anomalies were identified.There are no related non-conformances associated with this product/lot combination.Device history review : a device manufacturing records evaluation (mre) was performed.No related deviations or anomalies were identified.There are no related non-conformances associated with this product/lot combination.

• 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: 11588547
• MDR Text Key: 242913769
• Report Number: 1818910-2021-06405
• 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: 01/29/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-22-000
• Device Catalogue Number: 136522000
• Device Lot Number: D14110498
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 32 +5 BR; PINN MAR NEUT 32IDX52OD; PINNACLE SECTOR II CUP 52MM; ARTICUL/EZE BALL 32 +5 BR; PINN MAR NEUT 32IDX52OD; PINNACLE SECTOR II CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR