MAUDE Adverse Event Report: STRYKER GMBH X3 HUMERAL INSERT - 36MM X 6 CONSTRAINED; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5571-C-3606
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Hospital policy.
Event or Problem Description
Revision surgery, reverse shoulder poly swap.
Additional Manufacturer Narrative
The reported event that x3 humeral insert - 36mm x 6 constrained was alleged of 'revision' could be confirmed.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.Indeed, the reason why the healthcare professional chose to exchange the poly was not mentioned in the complaint detail.Furthermore, no pictures were provided etiher.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
Revision surgery, reverse shoulder poly swap.

• Brand Name: X3 HUMERAL INSERT - 36MM X 6 CONSTRAINED
• Common Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8139816
• Report Number: 0008031020-2018-01032
• Device Sequence Number: 18899129
• Product Code: KWS
• UDI-Device Identifier: 07613327098617
• UDI-Public: 07613327098617
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 5571-C-3606
• Device Lot Number: 8K03VH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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: 68 YR
• Patient Weight: 102