MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL/EZE BALL 22.225+4 NK; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-29-000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Physical Asymmetry (4573)

Event Date 06/08/2021

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

It was reported that the patient dislocated during a physical therapy session.Was brought to or for open reduction.Head and liner were exchanged to lengthen the hip slightly due to leg length discrepancy noted by the patient but was intentionally left short after multiple surgeries due to contraction of soft tissues.Doi: (b)(6) 2021 dor: (b)(6) 2021 affected side: left 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ARTICUL/EZE BALL 22.225+4 NK
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12083460
• MDR Text Key: 258877162
• Report Number: 1818910-2021-13762
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033349
• UDI-Public: 10603295033349
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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: 1365-29-000
• Device Catalogue Number: 136529000
• Device Lot Number: D20101658
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 22.225+4 NK; BI MENTUM PFRK PE LINER 22 41; ARTICUL/EZE BALL 22.225+4 NK; BI MENTUM PFRK PE LINER 22 41
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR