MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 28 +8.5 BL; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136513000

Device Problems Disconnection (1171); Fracture (1260)

Patient Problems Injury (2348); Joint Dislocation (2374); Not Applicable (3189)

Event Date 06/29/2018

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

It was reported that the outer locking ring for this patient's pinnacle constrained liner apparently became disassociated from the liner a few years ago, according to the surgeon.The patient's hip was functioning well, despite the disassociated locking ring, until last week.The patient's hip became dislocated, requiring it to be revised.The constrained liner, which appeared to be cracked, and the original articuleze femoral head were replaced with a matching liner and head.They were then replaced by an alternate liner and head minutes later, after it was discovered that the initial replacement liner was damaged slightly while being inserted into the well fixed acetabular cup.The initial liner, along with its inner locking ring, were badly damaged during the explant portion of the revision surgery.The initial loosening interface, the dislocation, was between the femoral head and the liner.Doi: (b)(6) 2008; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned femoral head finds nothing outward that would suggest product error.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ARTICUL/EZE BALL 28 +8.5 BL
• 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 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46582 ; 6103142063
• MDR Report Key: 7717756
• MDR Text Key: 114946006
• Report Number: 1818910-2018-65136
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033103
• UDI-Public: 10603295033103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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 Catalogue Number: 136513000
• Device Lot Number: 2120308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR