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

Model Number	1360.50.810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing and sterilization charts of the components involved in the event, no pre-existing anomaly was discovered in the items belonging to the same product codes and lot numbers as the devices hereby reported.No additional information was received from the complaint source; therefore, no further investigation can be carried out in this event.However, taking into account that: checking the manufacturing and sterilization charts of the components involved in this event, no pre-existing anomaly has been found, that could have contributed to the event.We have no evidence to consider the event as product-related.Pms data: based on the relevant pms data, the revision rate of the smr reverse liners belonging to the families 1360.50.Xxx, 1361.50.Xxx, 1365.50.Xxx due to infection is around (b)(4).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
Revision surgery performed on (b)(6) 2025, due to infection.There was an infection from the skin incision, the surgeon wanted to do a poly swap.The following liner was the only component removed and replaced by a similar device: smr reverse liner standard (part code: 1360.50.810, lot number: 22at1gh, sterilization 2200243).The other components were left in situ: smr metal-back glenoid small r (part code: 1375.21.005, lot number: 2433154, sterilization 2500010).Smr small-r connector +2 (part code: 1374.15.312, lot number: 2500708, sterilization 2500041).Smr glenosphere dia.36mm (part code: 1374.09.111, lot number: 2436656, sterilization 2500015).Finned reverse hum.Body 140° (part code: 1352.15.051, lot number: 2416428, sterilization 2400165).Smr cementless finned stem (part code: 1304.15.140, lot number: 2312939, sterilization 2300232).Previous surgery took place on (b)(6) 2025.The patient is a female, date of birth on (b)(6) 1969.The event happened 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: 22288364
• Report Number: 3008021110-2025-00076
• Device Sequence Number: 15683916
• Product Code: PHX
• UDI-Device Identifier: 08033390080613
• UDI-Public: 08033390080613
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• 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): 06/18/2025

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: 1360.50.810
• Device Lot Number: 22AT1GH
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• 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