MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; REVERSE LINER 40MM +3MM

Model Number	1365.50.815
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts, no pre-existing anomalies were found in the 69 items belonging to the lot number 22at0nb and sterilization (b)(4).This is the first and only complaint registered on this lot number.We tried to clarify with the complaint source if the dislocation was caused by a sub-optimal choice of the implant made by the surgeon during the primary surgery, but we were unable to recover this information.Therefore, taking into account that: no pre-existing anomalies were found by checking the manufacturing charts of the component removed in the revision surgery hereby reported this is the first and only complaint registered on this lot number.We have no evidence to consider the event as product related.Pms data based on the available pms data, the revision rate of smr reverse liners belonging to the family product code 1360.50.Xxx - 1361.50.Xxx - 1365.50.Xxx due to dislocation is around 0.08%.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.
Event or Problem Description
Shoulder revision surgery was performed on (b)(6) 2025, due to dislocation.The surgeon implanted a thicker liner.Therefore, the only component removed and replaced by a new one is the following: smr reverse liner +3mm d.40mm (part code 1365.50.815, lot number 22at0nb, sterilization (b)(4).The other components previously implanted were left in situ: tt augm.360 baseplate #s-r+2mm (part code 1375.15.522, lot number 2211656, sterilization (b)(4).Smr reverse humeral body short (part code 1352.15.005, lot number 2202509, sterilization (b)(4).Smr glenosphere ø 40mm (part code 1374.09.121, lot number 2206405, sterilization (b)(4), smr connector small r (part code 1374.15.305, lot number 2213086, sterilization (b)(4), smr glenoid peg tt small-r #m (part code 1375.14.652, lot number 2213319, sterilization (b)(4).Smr cementless finned stem (part code 1304.15.180, lot number 2209462, sterilization (b)(4).Previous surgery took place on (b)(6) 2022.The patient is a female, date of birth (b)(6) 1951.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINER 40MM +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: 22872434
• Report Number: 3008021110-2025-00106
• Device Sequence Number: 13358740
• Product Code: PHX
• UDI-Device Identifier: 08033390102933
• UDI-Public: 8033390102933
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/22/2025

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: 1365.50.815
• Device Lot Number: 22AT0NB
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• 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