MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +9; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136532330

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)

Event Date 08/20/2019

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

The primary surgery was performed on (b)(6) 2019 via tha.It was reported that the removal surgery was performed on (b)(6) 2019 by explanting the stem (p/n: l20310), the head (p/n: 136532330) due to postoperative infection.The surgery was completed within a 30 minutes surgical delay.No further information is available.

Manufacturer Narrative

Product complaint #: (b)(4).This is a duplicate report of 1818910-2019-102855.1818910-2019-104142 is being retracted as it is a report duplication.1818910-2019-102855 will be kept for investigation.

• Brand Name: DELTA CER HEAD 12/14 32MM +9
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9008452
• MDR Text Key: 157827580
• Report Number: 1818910-2019-104142
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033455
• UDI-Public: 10603295033455
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• 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: 08/21/2019

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: 136532330
• Device Lot Number: 8918054
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention