MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 40IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-40-056

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

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Chest Pain (1776); Edema (1820); Erythema (1840); Fatigue (1849); Fever (1858); Headache (1880); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

Ppf alleged infection.Pfs alleged pain, redness, and drainage.After review of medical records, patient was revised to address left infected total hip arthroplasty.Upon physical examination on (b)(6) 2018, patient has fever.Pain, swelling, redness, drainage, throbbing frontal headache, squeezing chest pain, and fatigue were alleged.Patient said incision is draining yellow to brown fluid but drainage has no odor.Operative notes indicated a communication was found between the superficial space and deep to the fascia.The superficial space was debrided.An excisional debridement of skin, subcutaneous tissue, fat and the fascia were done.The superficial space was then copiously irrigated.There was fluid deep to the fascia with purulence about 80 cc of purulent fluid.The capsule was debulked and scar tissue was removed.Scar tissue was also removed around the acetabular component.A thorough debridement of an infected looking tissue was done around the acetabulum and femur.After all infected looking tissues were excised the hip was irrigated with 9 liters of irrigation as well as betadine irrigation.Based on flouroscopy, there was no iatrogenic fractures.Laboratory results indicated infection.Doi: (b)(6) 2018 (liner & head) - dor: (b)(6) 2018 (left hip).Doi: (b)(6) 2010 (cup & stem).

Manufacturer Narrative

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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALTRX NEUT 40IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9836924
• MDR Text Key: 191455499
• Report Number: 1818910-2020-08111
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295393344
• UDI-Public: 10603295393344
• Combination Product (y/n): N
• PMA/PMN Number: K132959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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: 11/30/2022
• Device Model Number: 1221-40-056
• Device Catalogue Number: 122140056
• Device Lot Number: HM0265
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR