MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PROMOS HUMERAL STEM 3 NON-CEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	75006539
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a promos reverse shoulder arthroplasty, x-rays showed that the promos humeral stem 3 non-cem sheared off.On (b)(6) 2022 a revision surgery was performed.The current heath status of the patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, after a promos reverse shoulder arthroplasty, x-rays showed that the promos humeral stem 3 non-cem sheared off.It was communicated that the revision surgery has not taken place yet.Therefore, the device, used in treatment, was not returned for investigation.However, the relationship between the reported event and the device can be confirmed based on the provided x-rays.The batch number of the device was not communicated, therefore, a batch related product history review could not be conducted.A complaint history on part level did no reveal any further complaint with the same failure mode.According to ifu lit.No.12.25, ed.07/10, implant fracture is a known possible side effect.The failure mode and the severity are covered through the corresponding risk management file.Review of past corrective actions was performed.No further escalation is required.A medical investigation was initiated.The provided x-ray was reviewed, some radiolucency around the humeral side is visible.However, smith and nephew has not received adequate materials to fully evaluate the complaint.The reported failure mode can be confirmed, however the root cause stays undetermined after investigation.There is not enough information available to speculate about contributing factors.To date, the need for further actions is not indicated.The device is not sold anymore.Smith and nephew will monitor this device for further similar issues.

• Brand Name: PROMOS HUMERAL STEM 3 NON-CEM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13310759
• Report Number: 9613369-2022-00011
• Device Sequence Number: 4938282
• Product Code: KWS
• UDI-Device Identifier: 07611996037593
• UDI-Public: 07611996037593
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: 75006539
• Device Catalogue Number: 75006539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown