MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PROMOS REVERSE GLENOSPHERE ECCEN.Ø36/+5; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	75003708
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a shoulder replacement surgery, where a promos reverse glenosphere eccen.Dia36/+5 was implanted.The patient experienced a peri-prosthetic fracture of the humerus, which was treated with a revision surgery performed on (b)(6) 2022.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a patient experienced a peri-prosthetic fracture of the humerus, which was treated with a revision surgery performed on (b)(6) 2022.A promos reverse glenosphere eccentric dia36/+5 was explanted.The device, used in treatment was not returned for evaluation, therefore further analysis was not possible.However, the relationship between the reported event and the device can be confirmed, since an x-ray, confirming the reported complaint, was provided.The production documentation was not reviewed, because no batch number was communicated.The complaint history review confirmed that the complaint is in line with the current risk management.The ifu lit.No.12.25, ed.07/11 lists bone fracture as possible side effect.Review of past corrective actions was performed.No further escalation is required.Since only one undated x-ray was provided and no further medical documentation, a thorough medical assessment is not possible.The root cause stays undetermined after investigation.Based on the limited information it is not possible to speculate about factors which could have contributed to the reported issue.To date, further actions are not deemed necessary.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this device for further similar issues.

• Brand Name: PROMOS REVERSE GLENOSPHERE ECCEN.Ø36/+5
• 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: 13935457
• Report Number: 9613369-2022-00064
• Device Sequence Number: 3889000
• Product Code: KWS
• UDI-Device Identifier: 07611996087420
• UDI-Public: 7611996087420
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/12/2022

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 Catalogue Number: 75003708
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown