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 Puncture/Hole (1504)

Patient Problems Synovitis (2094); Implant Pain (4561); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  Injury  

Event Description

It was reported that the spacer punctured and displaced resulting in synovitis and the need for a revision surgery.

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.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: inspace spacer puncture.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 failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that the spacer punctured and displaced resulting in synovitis and the need for a revision surgery.

Event Description

It was reported that the spacer was punctured and caused increased shoulder pain.It was resulting in revision surgery that also detected synovitis in the implantation site.

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: inspace spacer puncture, which associate with the hazard of 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.H3 other text : 81.

• 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: 14044865
• MDR Text Key: 294540937
• Report Number: 0002936485-2022-00170
• Device Sequence Number: 1
• Product Code: QPQ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 0129
• Device Lot Number: 230919-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 03/11/2022; 03/11/2022
• Supplement Dates FDA Received: 06/03/2022; 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 99 YR
• Patient Sex: Male