MAUDE Adverse Event Report: STRYKER GMBH X3 HUMERAL INSERT - 36MM X 4MM STANDARD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5571-S-3604
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.
Event or Problem Description
The peripheral screws completely disassociated from the glenoid baseplate, even with the glenosphere intact.There was significant bone loss on the glenoid, and the micromotion from the baseplate & screws "rocking" left uncontained defects in the glenoid.There was metallosis around the implants and osteolysis around the humeral cup.Revision surgery occurred.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Note that no additional feedback (no x-rays.) was received from sales rep.Based on the given information, the root cause was attributed to be patient related.The failure was caused due to the fact as the patient suffers from osteolysis (also metallosis around the implants).Nevertheless more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The peripheral screws completely disassociated from the glenoid baseplate, even with the glenosphere intact.There was significant bone loss on the glenoid, and the micromotion from the baseplate & screws "rocking" left uncontained defects in the glenoid.There was metallosis around the implants and osteolysis around the humeral cup.Revision surgery occurred.

• Brand Name: X3 HUMERAL INSERT - 36MM X 4MM STANDARD
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8680421
• Report Number: 0008031020-2019-00534
• Device Sequence Number: 19246291
• Product Code: KWS
• UDI-Device Identifier: 07613327098457
• UDI-Public: 07613327098457
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/08/2022
• Device Catalogue Number: 5571-S-3604
• Device Lot Number: 646YNE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR