MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 CORAIL2 NON COL HO SIZE 14; HIP FEMORAL STEM

Model Number L20314

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

Patient Problems Adhesion(s) (1695); Erythema (1840); Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 12/27/2021

Event Type  Injury  

Event Description

Clinical adverse event received for infection deep vs superficial event is serious and is considered mild.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2021, date of event (onset): (b)(6) 2021, (left hip).Treatment: surgical joint aspiration, and superficial wound (superficial infections with subcutaneous induration) scrubbed with chlorhexidine and irrigated with ancef in 2 liters of fluid.

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

Patient presents with left hip pain, erythema, and swelling around left hip status post left tha.Physical exam identifies crusting around surgical side with induration and warmth.Gross puss was expressed from the site when decompressed and began to drain copiously.Surgeon is unsure is the infection is superficial or deep.Pus and drainage sent for stat culture and patient is scheduled for an i&d for the next day.Doe: patient received a left hip i & d to treat potential superficial infection of the incision site.Upon entering the joint, pus and drainage were evacuated, the wound cleaned and irrigated, and scar tissue debrided from the tfl.The infection did not appear to be present within the joint capsule.All devices were retained.The procedure was completed without complications.Patient was placed on a 6-week iv antibiotic therapy.Clinic visit dated (b)(6) 2022: patient presents for 6-week checkup status post left hip i & d.The incision site is healed, and patient is doing well.Iv antibiotic treatment will be discontinued in 2 weeks.Doi: (b)(6) 2021; doe: (b)(6) 2022: i & d no revision; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays were reviewed and no indication of a product defect was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL2 NON COL HO SIZE 14
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13392168
• MDR Text Key: 284682601
• Report Number: 1818910-2022-01902
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295258056
• UDI-Public: 10603295258056
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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: L20314
• Device Catalogue Number: L20314
• Device Lot Number: 5325284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 02/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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
• Treatment: ARTICULEZE M HEAD 36MM +5.; CORAIL STEM COLLARLESS HI OFFSET SZ 14.; PINNACLE ALTRX 54MM X 36MM +4 NEUTRAL.; PINNACLE SHELL SECTOR 54MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White