MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-06-000

Device Problem Fracture (1260)

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Scarring (2061); Weakness (2145); Hypoesthesia (2352); No Code Available (3191)

Event Date 09/13/2018

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

Medical records indicate fractured femoral head.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Claim letter received.Claim letter alleges that patient had a catastrophic failure of the left femoral component trunnion, requiring revision and extensive trochanteric osteotomy.

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.H6 patient code: no code available (3191) used to capture the device revision or replacement and joint instability 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.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: lot 7876692.A device history record (dhr) review was performed.Product code 136506000, work order 7876692 was manufactured on 26-mar-2014.14 parts were manufactured per specification and all raw materials met specification.Nr-0015018 is associated with this lot.On review of this nr it was found that it was related to foreign matter contamination due to the trays used for transportation between the cleanline and clean room.A preliminary risk assessment was conducted as per 103183987, pra-global unite: poly particles in taper, the review concluded that the defect has no patient risk.There is no correlation with this nonconformance and the failure mode.Device history review
=
> a device history record (dhr) review was performed.Product code 136506000, work order 7876692 was manufactured on 26-mar-2014.14 parts were manufactured per specification and all raw materials met specification.Nr-0015018 is associated with this lot.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+5
• 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: 8132445
• MDR Text Key: 129300550
• Report Number: 1818910-2018-77164
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295032984
• UDI-Public: 10603295032984
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2018

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 Model Number: 1365-06-000
• Device Catalogue Number: 136506000
• Device Lot Number: 7876692
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 12/02/2019; 06/01/2020; 07/08/2020
• Supplement Dates FDA Received: 12/31/2019; 06/10/2020; 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 40IDX58OD; CORAIL2 LAT COXA VARA SIZE 13; PINNACLE MULTIHOLE II CUP 58MM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR