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 Adhesion(s) (1695); Joint Laxity (4526); Physical Asymmetry (4573)

Event Date 07/23/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

Patient presented to hcp approximately 4 months post-operatively of her primary hip replacement after she felt something 'give' in her hip.She immediately detected a squeak in her hip indicating something had changed.She had no pain and walked normally.She has in a metal on polyethylene bearing, so squeak is not expected.The surgeon suspected the acetabular liner may have dislodged from the shell.This was from radiographic analysis.Patient was taken to theatre today (within 24hrs) and when opened, it was confirmed that the acetabular liner was dislodged from the pinnacle shell.The squeak was deemed to have been the metal head rubbing on the inside of the pinnacle shell where the dislodged liner should have been.A new replacement liner and femoral head were inserted, hip reduced and routine closure.The surgeon is confident all will be well.The concern was why the liner disengaged from the shell.There were also 2 missing lugs on the periphery of the liner.Revision operative notes (b)(6) 2021 indicate the patient received a right total hip revision.In addition to what has been previously reported, the patient also experienced a 4-8mm leg length discrepancy pre-revision and adhesions were encountered and removed once in the joint.The surgery was completed without complication indicated.

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.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 worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• 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: 12337444
• MDR Text Key: 267094955
• Report Number: 1818910-2021-18083
• 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: 07/23/2021

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: D19062026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX52OD; ARTICUL/EZE BALL 32 +5 BR; PINNACLE 300 ACET CUP 52MM; ALTRX NEUT 32IDX52OD; ARTICUL/EZE BALL 32 +5 BR; PINNACLE 300 ACET CUP 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 70