MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE INSPACE? IMPLANT - LARGE; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL

Catalog Number 0129

Device Problem Material Rupture (1546)

Patient Problems Implant Pain (4561); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  Injury  

Event Description

It was reported that the device ruptured and required a revision surgery to explant the device.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the device ruptured and required a revision surgery to explant the device.

Manufacturer Narrative

The device manufacturer date is not known.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: balloon filling problem.Probable root cause: design inadequate spacer/plug/sleeve design inadequate raw material specification process spacer or plug not manufactured to specification incorrect material used during manufacture application implant used in contraindicated or ill-advised patient population incorrect spacer size selection spacer contact with other implants user underinflated or overinflated spacer patient noncompliant with post-op rehabilitation schedule or exposed to too intensive pt inflammatory reaction use of more than one spacer within joint.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: volume reduction post-operative probable root cause: design: inadequate spacer/plug/sleeve design.Inadequate raw material specification.Process: spacer or plug not manufactured to specification.Incorrect material used during manufacture.Application: implant used in contraindicated or ill-advised patient population.Incorrect spacer size selection.Spacer contact with other implants.User underinflated or overinflated spacer.Patient noncompliant with post-op rehabilitation schedule or exposed to too intensive pt.Inflammatory reaction.Use of more than one spacer within joint.The reported failure mode will be monitored for future reoccurrence.Manufacturing date is unknown.H3 other text: 81.

Event Description

It was reported that the device ruptured and required a revision surgery to explant the device.

Manufacturer Narrative

Correction: the incorrect fda registration number was used during the initial report.The correct fda registration number is 3016573902.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The investigation was based on the review of product dhr and the device risk file.The dhr was reviewed with no findings or non-conformance.The device was released per required specifications alleged failure: balloon filling problem and rupture along edge of balloon probable root cause: design.Inadequate spacer/plug/sleeve design.Inadequate raw material specification.Process.Spacer or plug not manufactured to specification.Incorrect material used during manufacture application.Implant used in contraindicated or ill-advised patient population.Incorrect spacer size selection.Spacer contact with other implants user.Underinflated or overinflated spacer patient noncompliant with post-op rehabilitation schedule or exposed to too intensive pt.Inflammatory reaction.Use of more than one spacer within joint.Post operative shoulder pain due to device premature deflation/volume reduction or displacement is an expected risk(s) that documented in the existing risk management file and ifu.However, it associated with various reasons, therefore the exact root cause could not be determine.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the patient had secretion from the surgical site and shoulder pain.During the revision surgery the device was found ruptured and displaced.

• Brand Name: INSPACE? IMPLANT - LARGE
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13397225
• MDR Text Key: 284797649
• Report Number: 0002936485-2022-00056
• Device Sequence Number: 1
• Product Code: QPQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0129
• Device Lot Number: 150719-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other