MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-320

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

Patient Problems Abscess (1690); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Swelling (2091); Tissue Damage (2104); No Code Available (3191)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was subjected to 2 surgical procedures of hip arthroplasty (left and right): the first one on (b)(6) 2009 and the second one on (b)(6) 2009.Immediately the patient started to accuse pain at hip, headache , general weakness and affordable breathing.During (b)(6) 2016, due to the aggravation of the symptoms in addition to fever and painful tumefection, went to (b)(6) hospital in which was diagnosed periprosthetic abscess.The patient was so subjected to washing and drainage and pharmacological therapy.

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: DELTA CER HEAD 12/14 36MM +5
• 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: 10298082
• MDR Text Key: 206648802
• Report Number: 1818910-2020-16258
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033622
• UDI-Public: 10603295033622
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

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 Expiration Date: 12/11/2013
• Device Model Number: 1365-36-320
• Device Catalogue Number: 136536320
• Device Lot Number: 2808739
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 36MM +5; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; SUMMIT POR TAPER SZ6 STD OFF
• Patient Outcome(s): Required Intervention