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

Model Number	1377.50.010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the liner removed, no pre-existing anomaly was found on the (b)(4) items belonging to the lot number: 19at132.Based on the available records, at least 39 out of (b)(6) items belonging to the lot number: 19at132 and sterilization: 1900326 have been implanted, and this is the first and only complaint received on this lot number.No additional information is available on this event; therefore, the manufacturer is not able to further investigate this case.Hence, taking into account that: the check of the manufacturing charts highlighted no pre-existing anomaly was found on the items belonging to the same product and lot number as the component removed.No further information about the causes of the rotator cuff tear was provided by the complaint source.We have no evidence to consider the event as product related.Pms data: according to pms data, the revision rate of smr anatomic prosthesis (total and hemi) due to cuff failure is around 0.52%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.The manufacturer continues monitoring the market to promptly detect any 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 failed rotator cuff.The implant was converted from anatomic to reverse.The following component was removed: liner f.Met.Back glen.Standard (part code: 1377.50.010, lot number: 19at132, sterilization: 1900326).Previous surgery took place on (b)(6) 2020.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: LINER FOR METAL-BACK (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: 22517822
• Report Number: 3008021110-2025-00092
• Device Sequence Number: 8927892
• 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 Implanted Year: 2020
• 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): 07/16/2025

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: 19AT132
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• 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