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

Model Number	1360.50.810
Medical Device Problem Codes	Break (1069); Degraded (1153); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since lot number is unknown.No x-rays nor pictures of explanted components were provided either.From follow-up communication with complaint source it was confirmed that no further information regarding the case can be retrieved, therefore no further root cause investigation is possible.Taking into account the involved product family smr shoulder, no adverse trend has been identified for reported issue in the last year.According to investigation carried out, no corrective action is needed for this event.If any additional information is received that would change or alter any conclusion, a supplemental report will be filed accordingly.The manufacturer will continue monitoring the market in order to detect any similar event.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 on a reverse shoulder prosthesis.Previous surgery is unknown, as well as complete product information of original assembly.Reportedly, the reverse shoulder prosthesis has been implanted for several years before failing.According to information provided, the glenosphere rotated, leading the poly liner to wear and eventually breaking, which caused pain and instability for the patient.During revision the surgeon removed the pre-existing smr metal-back glenoid std (part number 1375.21.010), smr glenosphere ø36 mm (part number 1374.09.110) and the broken smr reverse liner standard (part number 1360.50.810) and implanted a new liner reverse liner +3mm (part number 1365.50.815).No information regarding glenoid components implanted in revision has been provided.However, surgery has been completed as intended.Patient is female, date of birth (b)(6) 1957.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) 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: 24201332
• Report Number: 3008021110-2026-00080
• Device Sequence Number: 14829738
• Product Code: PHX
• UDI-Device Identifier: 08033390273589
• UDI-Public: 8033390273589
• 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): 01/28/2026

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: 1360.50.810
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• 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