MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; LINER FOR METAL-BACK (UHMWPE) LINER STANDARD

Model Number	1377.50.010
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to infection.Infection indicated removal of all the following implants: - smr cementless finned stem (part code 1304.15.220, lot number 1606114, sterilization unknown).- smr finned humeral body (part code 1350.15.110, lot number 1518947, sterilization unknown).- smr metal-back glenoid std (part code 1375.21.010, lot number 1707510, sterilization unknown).- liner f.Met.Back glen.Standard (part code 1377.50.010, lot number 14l0897, sterilization (b)(4)).Successful removal occurred.Date of previous surgery unknown.The patient is a male.The event happened in the united states.
Additional Manufacturer Narrative
Investigation: checking the manufacturing and sterilization charts of the liners with lot number 14l0897 and sterilization (b)(4), no pre-existing anomaly has been found out in the (b)(4) items belonging to the same lot number.According to our records, at least (b)(4) liners with lot number 14l0897 and sterilization (b)(4) have been implanted and this is the only complaint received on this lot number.Since this is the only component for which we received information on the sterilization number, for the other components involved in the event we carried out a check on the manufacturing charts for all the sterilization numbers, without finding any pre-existing anomaly.Hence, considering that: - no pre-existing anomaly was found by checking the manufacturing and sterilization charts of the liners belonging to the lot 14l0897 we have no evidence to consider the event as product related.Pms data: according to the relevant pms data, the revision rate of the liners belonging to the family code 1377.50.0xx 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.

• Brand Name: SMR SHOULDER
• Common Device Name: LINER FOR METAL-BACK (UHMWPE) LINER 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: 22078131
• Report Number: 3008021110-2025-00058
• Device Sequence Number: 9363137
• Product Code: PHX
• UDI-Device Identifier: 08033390002608
• UDI-Public: 08033390002608
• Combination Product (Y/N): N
• PMA/510(K) Number: K113254
• 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): 05/23/2025

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: 1377.50.010
• Device Lot Number: 14L0897
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• 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