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

Model Number 0132

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Skin Infection (4544); Implant Pain (4561); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2022

Event Type  Injury  

Event Description

It was reported that the patient had an infected shoulder requiring an arthroscopic wash out.

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 patient had an infected shoulder requiring an arthroscopic wash out.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.However it was reported that the patient was diagnosed with rheumatoid arthritis.In the event that further information is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: material elicits physiological adverse reaction probable root cause: design - wrong raw material or manufacturing agent selected - in-process cleaning not effective at removing manufacturing residuals - not enough strict controls placed on raw material source and purity process - sterilization fault - including eto residuals - contamination during manufacturing process; including endotoxins - in-process cleaning not performed to spec application - contamination of instruments - patient reaction/allergy sensitivity or with active/latent infection - use of contrast media - use of more than one implant within the shoulder - wrong patient selection probable root cause: design - inadequate raw material specification process - incorrect material used during manufacture application - implant used in contraindicated or ill-advised patient population or patient pre-conditions - use of expired product - re-use of single-use device - use of contrast media - degradation accelerated by inflammatory reaction - patient not following rehab protocol the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

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.However it was reported that the patient was diagnosed with rheumatoid arthritis, which is a clinical condition that associated with immune disorder and can contribute to the development of infection post device implantation.In the event that further information is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: material elicits physiological adverse reaction.Probable root cause: design: wrong raw material or manufacturing agent selected.In-process cleaning not effective at removing manufacturing residuals.Not enough strict controls placed on raw material source and purity.Process: sterilization fault - including eto residuals.Contamination during manufacturing process; including endotoxins.In-process cleaning not performed to spec.Application: contamination of instruments.Patient reaction/allergy sensitivity or with active/latent infection.Use of contrast media.Use of more than one implant within the shoulder.Wrong patient selection.Probable root cause: design.Inadequate raw material specification.Process: incorrect material used during manufacture.Application: implant used in contraindicated or ill-advised patient population or patient pre-conditions.Use of expired product.Re-use of single-use device.Use of contrast media.Degradation accelerated by inflammatory reaction.Patient not following rehab protocol.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the patient had shoulder pain 4 months post implantation and diagnosed with an infected shoulder requiring an arthroscopic wash out.

• Brand Name: INSPACE US 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): ORTHOSPACE LTD.; 7 halamish st.; caesarea CA 30795 79; IS 3079579
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14349738
• MDR Text Key: 291344158
• Report Number: 0002936485-2022-00222
• Device Sequence Number: 1
• Product Code: QPQ
• UDI-Device Identifier: 17290013396065
• UDI-Public: 17290013396065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0132
• Device Catalogue Number: 0132
• Device Lot Number: 010621-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2022
• 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