MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-054

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 02/04/2019

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

It was reported the patient was with right femoral head ischemic necrosis and had a right total hip arthroplasty and hip arthrolysis on (b)(6) 2018.On (b)(6) 2019, the patient noted the wound exuded fluid.The patient was in hospital on (b)(6) 2019 and had an anti-infective treatment with broad-spectrum antibiotics and regular disinfection.Doi: (b)(6) 2018.The patient was implanted with pinnacle cup to treat ischemic necrosis of the right femoral head.Date of incident: (b)(6) 2019.The patient was re-admitted to the hospital and reported oozing wound exudate.The surgeon diagnosed poor wound healing and a postoperative wound infection.The patient was treated with parenteral and oral antibiotics, as well as daily manual wound disinfection and dressing changes.The wound was fully healed on (b)(6) 2020 with no indication of infection.No revision was performed, and no product defects were reported.Doi: (b)(6) 2019, date of incident: (b)(6) 2019, right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE SECTOR II CUP 54MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9801763
• MDR Text Key: 183264924
• Report Number: 1818910-2020-07138
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009832
• UDI-Public: 10603295009832
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 03/07/2019

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 Model Number: 1217-22-054
• Device Catalogue Number: 121722054
• Device Lot Number: 8770073
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR