MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2021

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

Article entitled: staphylococcus saccharolyticus associated with prosthetic joint infections: clinical features and genomic characteristics by bo s¿derquist, mastaneh afshar, anja poehlein, and holger br¿ggemann, published by pathogens 2021, 10, 397, was reviewed.The article investigated five competitor hips that were revised having presented as aseptic implant loosening, but following routine intraoperative specimen collections, determined to be chronic, insidious, low-grade prosthetic joint infectionsthe organism being staphylococcus saccharolyticusa member of normal skin flora.The article also presented two depuy acute shoulder arthroplasty infections, infected with staphylococcus saccharolyticus and cutibacterium acnes (both identified through routine intraop specimens collected).The article brings to light that staphylococcus saccharolyticus has the potential to cause prosthetic joint infections that can present insidiously as aseptic implant loosening.For purposes of this complaint, only the shoulders will be addressed.Patient 6, a (b)(6) year-old male, initially received a depuy global fx shoulder hemiarthroplasty in 2012, to treat a complicated, proximal humerus traumatic shoulder fracture.At day 17 after primary surgery, presented with pain, swelling, and local inflammation of the shoulder.On day 21, polymicrobial staphylococcus saccharolyticus was grown in 5 of 5 of collected intraop specimens, and cutibacterium acnes was grown in 4 of 5.Patient was prescribed penicillin v for 4 months, and ultimately revised 1 month post-operatively (no revision details provided).It was also reported that one year later, the patient experienced poor functional status, with rom limited to 30 degrees, although the infection was determined to be cured.Patient 7, a (b)(6) year-old male, received a depuy global unite total shoulder arthroplasty to address secondary native septic arthritis of the shoulder that was caused by staphylococcus aureus osteomyelitis.It had been treated for three months with penicillin, and then a year after completion of treatment of the infection, received the total shoulder arthroplasty to address the secondary arthritis.The patient was started on clindamycin immediately post-op, and later replaced with penicillin v for an additional 3 months.Intraop specimens ultimately grew staphylococcus saccharolyticus in 3 of 5 of collected intraop specimens, and cutibacterium acnes was grown in 1 of 5.Upon discontinuation of the antibiotics, patient presented with increased pain in the shoulder, although inflammatory marker crp labs remained low at <4mg/l.Additional surgical tissue biopsies collected later in a second procedure, grew staphylococcus saccharolyticus in 2 of 6, and cutibacterium acnes in 1 of 6 of collected specimens.Shoulder was then treated with amoxicillin, and one month later, a complete explantation of the shoulder prosthesis was performed.All tissue biopsies obtained in that surgical procedure showed no growth.Treatment with amoxicillin was given for three months.A shoulder prosthesis was reimplanted five months after extraction of the infected prosthetic devices.Perioperative cultures at that operation showed no growth.A follow-up after a year showed good functional status of the shoulder.With respect to both primary shoulder prosthesis, no cement manufacturer was identified.The humeral stem interface was also unidentified in both accounts.The manufacturer of the revision products was not identified in either case following treatment of the infections.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN SHOULDER HUMERAL STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12410920
• MDR Text Key: 270832983
• Report Number: 1818910-2021-19139
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

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: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention