MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; REVERSE RETENTIVE LINER 40MM STANDARD

Model Number	1365.50.811
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing and sterilization charts of the devices removed during the revision surgery hereby reported, no pre-existing anomaly was discovered on the items belonging to the same product codes and lot numbers.The manufacturer will submit the final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025.It was reported that the patient presented with a large, unexplained hematoma.The surgeon suspected an infection; therefore, the wound was flushed, and the liner was swapped.During the procedure, the surgeon noted that the implant was too loose, so the version was adjusted, and extensions were added.The following smr reverse finned humeral body and an smr reverse retentive liner were replaced during this surgery: smr reverse finned humer.Body (part code 1352.15.050, lot number 2415343, sterilization (b)(4)).Smr reverse liner retentive (part code 1365.50.811, lot number 22at145, sterilization (b)(4) ).The revision stem smr cementl.Rev.Stem ø15 mm (part code 1308.15.156, lot number 1810713, sterilization (b)(4)) remained in situ.Previous surgery took place on (b)(6) 2025.The patient is a male, date of birth (b)(6) 1948.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE RETENTIVE LINER 40MM STANDARD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 22381445
• Report Number: 3008021110-2025-00095
• Device Sequence Number: 9483287
• Product Code: PHX
• UDI-Device Identifier: 08033390102964
• UDI-Public: 08033390102964
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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
• Device Model Number: 1365.50.811
• Device Lot Number: 22AT145
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• 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: Unknown