MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 32 +17 WH; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-25-000

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 09/18/2020

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

Clinical notification received for revision of left total hip to address aseptic loosening and adverse local tissue reaction.Date of implantation: (b)(6) 2008, date of revision: (b)(6) 2020.Treatment: femoral stem, femoral head, and acetabular liner revised.

Event Description

The surgeon noted placing a constrained liner due to multiple dislocations following the first revision.

Manufacturer Narrative

Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and h6 (patient).Corrected: h6 (device).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2020, the patient underwent a second left hip revision due to pain, instability, stiffness, arthrofibrosis, metallosis, inflammation, edema, difficulty walking, limb asymmetry, and a loose and migrated femoral stem.The surgeon also noted placing a constrained liner due to multiple dislocations following the first revision.There is no evidence of prior treatment for the dislocations.The cup was retained during the revision.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.No code available (3191) is used to capture joint instability and limb asymmetry if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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.

• Brand Name: ARTICUL/EZE BALL 32 +17 WH
• 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: 10727293
• MDR Text Key: 212752217
• Report Number: 1818910-2020-23235
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033219
• UDI-Public: 10603295033219
• Combination Product (y/n): N
• PMA/PMN Number: K883460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2020

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: 1365-25-000
• Device Catalogue Number: 136525000
• Device Lot Number: 2500340
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/22/2020; 10/20/2020; 11/25/2020
• Supplement Dates FDA Received: 10/26/2020; 11/10/2020; 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +17 WH; CORAIL2 LAT COXA VARA SIZE 13; PINN MAR LIP LNR 32IDX54OD; PINNACLE 100 ACET CUP 54MM; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +17 WH; CORAIL2 LAT COXA VARA SIZE 13; PINN MAR LIP LNR 32IDX54OD; PINNACLE 100 ACET CUP 54 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 85