MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; REVERSE LINERS 36MM (UHMWPE) +3MM

Model Number	1360.50.815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the device removed during this revision surgery, no pre-existing anomaly was found in the items manufactured with the lot number 22at1yh.Since the correct sterilization number is unknown, we checked the documentation of all the sterilization numbers linked to the lot 22at1yh, without finding any pre-existing anomaly.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to stiff shoulder.Previous surgery date unknown.The following component was removed and replaced by a new one: - smr reverse liner + 3 mm (part code 1360.50.815, lot number 22at1yh, sterilization unknown).The patient is a female, date of birth (b)(6) 1955.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) +3MM
• 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: 23389241
• Report Number: 3008021110-2025-00135
• Device Sequence Number: 21340691
• Product Code: PHX
• UDI-Device Identifier: 08033390080620
• UDI-Public: 08033390080620
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/27/2025

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: 1360.50.815
• Device Lot Number: 22AT1YH
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2025
• 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