MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 7; CEMENTLESS HUMERAL DIAPHYSIS

Model Number	04.01.0180
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 april 2022.Lot 2100443: (b)(4) items manufactured and released on 05-may-2021.Expiration date: 2026-apr-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by clinical affairs specialist.Revision in a rsa two days after the index surgery.The pain reported by the patient may be due to stem subsidence.From the radiographic images, it seems that the stem implanted in the index surgery was undersized and this may have caused the stem subsidence.The reason of this choice is unknown.No further conclusion can be drawn with the elements at hand.Investigation performed by r&d project manager.The stem appears to be qualitatively undersized relative to the humerus.However, as also reported in the surgical technique, sizing is done based on rasp stability during humeral preparation and is then verified during stem impingement.Stability depends on bone quality and is not necessarily given by contact with the internal cortical, so looking only at the x-rays received it is impossible to define that it is undersized.Because we did not receive a post-op (or intra-op) x-ray and a pre-revision x-ray in the same projection, it is not possible to say with certainty that this is stem subsidence or whether it was implanted in a particularly 'inset' position.
Event or Problem Description
The patient came in reporting pain due to a humeral stem subsidence due to an undersized stem.The reason for the undersized stem is unknown.At 2 days after the primary surgery, the surgeon revised the glenosphere, liner, metaphysis and diaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 7
• Common Device Name: CEMENTLESS HUMERAL DIAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14191936
• Report Number: 3005180920-2022-00315
• Device Sequence Number: 4556612
• Product Code: PHX
• UDI-Device Identifier: 07630040715881
• UDI-Public: 07630040715881
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2026
• Device Model Number: 04.01.0180
• Device Catalogue Number: 04.01.0180
• Device Lot Number: 2100443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2021
• 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
• Patient Sex: Male