MAUDE Adverse Event Report: STRYKER/ORTHO-SPACE LTD. INSPACE BALLOON IMPLANT FOR SHOULDER; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL

Patient Problems Pain (1994); Osteomyelitis (4533); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/20/2022

Event Type  Injury  

Event Description

I had an inspace implanted in my right shoulder on (b)(4) 2022 within a few days i had increased pain, swelling.My dr (b)(6) disregarded the situation until i couldn¿t stand it and went to er where i had to have device removal and 3-4 washout surgeries, iv antibiotics.I was hospitalized for 44 days.I also had an aki in which i did not recover and have ckd3b.The washout caused muscle loss, rotator cuff loss, frozen shoulder, osteomyelitis.A year later i had an antibiotic loaded spacer placed because this issue required me to have a reverse total shoulder placed.

• Brand Name: INSPACE BALLOON IMPLANT FOR SHOULDER
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• Manufacturer (Section D): STRYKER/ORTHO-SPACE LTD.
• MDR Report Key: 18588851
• MDR Text Key: 333961861
• Report Number: MW5150765
• 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: Patient
• Type of Report: Initial
• Report Date: 01/22/2024

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE.; LEVOTHYROXINE.; MULTIVITAMIN. ; MULTIVITAMIN. ; VITAMIN D3.
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Life Threatening; Disability
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White