MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS, SIZE 10, 135°

Model Number	04.01.0027
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months from primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all medacta hardware and implanted a spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 21-11-2024.Lot 1901138a: (b)(4) items manufactured and released on 12-12-2019 expiration date: 2024-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event during the period of review.Additional components involved in the event: batch review performed on 21-11-2024.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot 1905791: (b)(4) items manufactured and released on 22-10-2019 expiration date: 2024-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0097 metal humeral head ø54 (k170910) lot 1903167: (b)(4) items manufactured and released on 12-08-2019 expiration date: 2024-07-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0134 hc pegged glenoid ø52 (k170910) lot 181492: (b)(4) items manufactured and released on 13-06-2018 expiration date: 2023-06-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0183 short humeral diaphysis - cementless - (b)(4) (k180089) lot 1905769: (b)(4) items manufactured and released on 18-09-2019 expiration date: 2024-08-26.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Conclusions: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS, SIZE 10, 135°
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20843847
• Report Number: 3005180920-2024-01028
• Device Sequence Number: 19775745
• Product Code: KWS
• UDI-Device Identifier: 07630040712651
• UDI-Public: 07630040712651
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 11/26/2024
• Device Model Number: 04.01.0027
• Device Lot Number: 1901138A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2019
• 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 Age: 49 YR
• Patient Sex: Male