MAUDE Adverse Event Report: STRYKER ENDOSCOPY INSPACE SHOULDER BALLON; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL

Model Number 0132

Patient Problems Subclinical Infection (2247); Implant Pain (4561)

Event Date 09/18/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 pt had stryker inspace shoulder balloon placed in surgery.Procedure was right shoulder arthroscopy with balloon spacer placement.Surgery went as planned mfr # 0132, lot # 170522-01.Note from (b)(6) 2023 all conversations: physical therapy (newest message first) (b)(6) 2023, (b)(6) back office pool (supporting (b)(6) pa) (b)(6) 2023 7:39 am.And it's swollen and hurts like (profanity).(b)(6) back office pool (supporting (b)(6) pa) (b)(6) 2023 4:38 am: went to therapy yesterday and within half hour i was in 9 to 10 pain.Took the rest of my pain pills and iced through out the night.What should i do next? never had any pain like this.Hpi: the patient is a pleasant 75 year old male following up after surgery.On (b)(6) 2023 office visit the patient reports he went to physical therapy for the first time yesterday and had significant pain.He was doing very well after the surgery until then.He cannot recall any specific incident or popping or movement of anything in the shoulder.He reports about 10-20 minutes after his first physical therapy session, he started having severe pain in the shoulder.It also became very swollen.He denies any fevers or chills.He says the pain is about a 9/10.Date/type of surgery: (b)(6) 2023: right shoulder arthroscopy with balloon spacer placement pain severity/location: right shoulder globally associated numbness: none physical: exam: there is no height or weight on file to calculate bmi.General: well dressed.Well nourished.No acute distress neuropsych: mood appropriate.Alert and oriented x 3 station: no truncal ataxia.Balance is normal.Re cv: extremities perfused without cyanosis, varicosities, or edema.Sensory: intact.Motor: intact.Wound: incisions healed.There is an approximately 3cm circular enlargement imaging: ultrasound performed by dr (b)(6) today in the office, of the right shoulder shows: effusion in the anterior shoulder along the bump.The balloon appears to be slipping posteriorly 2 weeks status post right shoulder arthroscopy with balloon spacer placement.Posterior slipping movement of the balloon.There is effusion in the anterior shoulder, likely from the movement of the balloon pushing on the joint.Therefore, possible concern for infection.We had a full discussion about the options.The first option is to pop the balloon today in the office.The second option is for the patient to push the implant back into position on his own with pendulum exercises for the next few days.The third option is to go back into surgery to either remove the balloon and replace it with another balloon, or to place another balloon into the space.The fourth option is to do a reverse total shoulder replacement.After a full discussion, the patient elects to move forward with option #2 to attempt to push the implant back into position on its own.We will see the patient back on friday to see if we need to pop the implant.For now, we will send an rx for pain control with percocet and antibiotics for keflex 500 mg qid x 7 days.Supervising physician, dr.(b)(6), was present and examined the patient with me.He agrees with the plan.(b)(6), pa-c the shoulder and (b)(6) office visit (b)(6) 2023.The patient reports he is still in pain but has improved since last visit 3 days ago.Date/type of surgery: (b)(6) 2023 right shoulder arthroscopy with balloon spacer placement pain severity/location: right shoulder no fevers or chills.Physical: exam: there is no height or weight on file to calculate bmi.General well dressed.Well nourished.No acute "dis".

• Brand Name: INSPACE SHOULDER BALLON
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 18394346
• MDR Text Key: 331440011
• Report Number: MW5149547
• Device Sequence Number: 1
• Product Code: QPQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0132
• Device Lot Number: 170522-01
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male