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

Model Number 0131

Patient Problems Fall (1848); Failure of Implant (1924); Swelling/ Edema (4577)

Event Date 04/11/2024

Event Type  Injury  

Event Description

On (b)(6) 2024.The patient had a shoulder arthroscopy with a stryker inspace balloon implanted without any visible complications.The product rep and surgeon said it was successful.On (b)(6) 2024, the patient fell and injured his shoulder while trying to catch himself during the fall.On (b)(6) 2024, a shoulder x-ray showed a new tiny man-made density projecting between the acromion and the humeral head measuring 4x1 mm.On (b)(6), an ultrasound of the shoulder showed "a small amount of fluid is identified in between the acromion and head of the humerus.More inferior and deeper, along the proximal/medial humeral head there is a collection of fluid measuring 3.4 x 2.2 x 2.3 cm." shoulder x-ray on (b)(6) 2024 showed "there is a relatively similar appearance of the right shoulder.There is a metallic clip in the subacromial space.There are small spurs at the lateral margin of the acromion process.The examination is otherwise unremarkable without evidence of fracture or malalignment." on (b)(6) 2024, the patient had surgery to remove the failed implant.Findings were "removal stryker in space balloon removed intact without fluid with metal fragment inside it." per the surgeon, the tip of the inflation cannula broke off in the neck of the balloon.The cannula cannot be observed prior to surgery for a comparison after surgery.Had the patient not fallen and sought treatment, the balloon would have dissolved and the fragment would have fallen into the joint space.

• Brand Name: ORTHOSPACE INSPACE SYSTEM
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 19142924
• MDR Text Key: 340752383
• Report Number: MW5154000
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0131
• Device Catalogue Number: 0131
• Device Lot Number: 190123-07
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Patient Sequence Number: 1
• Treatment: ALIROCUMAB.; ASPIRIN.; CHOLECALCIFEROL.; FERROUS SULFATE.; FISH OIL.; MAGNESIUM OXIDE.; RIBOFLAVIN.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White