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

Model Number	1361.50.810
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records for involved batch did not identify any pre-existing anomaly or non conformity relevant to te issue.Explanted component has been discarded, therefore it is not available for inspection, and no pictures were provided either.However from follow-up communication with sales representative it was confirmed that the explanted liner was in good condition, with no indication of product failure.X-rays were not available for further investigation.Complaint database review identified no further complaint from the market on involved lot out of total 64 manufactured units, thus excluding a systematic quality issue.Hence, taking into account that: no anomalies were identified in dhr, no further complaints were reported on involved lot, explanted liner was in good condition, reported instability issue was solved increasing the thickness of the implant, the manufacturer has no evidence to consider the event as product related.Based on the available pms data, the revision rate of smr reverse liners, belonging to the family product codes 1360.50.Xxx, 1361.50.Xxx and 1365.50.Xxx due to instability is around 0.03% according to the investigation carried out, no corrective action is needed for this event.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) 2026 due to shoulder instability.Previous surgery is unknown, as well as complete product information of original implant.During revision surgery, the pre-existing smr rever.Liner retentive std (part number 1361.50.810, lot 22at144, sterilization (b)(4)) was removed and replaced with a thicker one.Surgery was completed as intended.The patient is female, date of birth-(b)(6) 1949.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) RETENTIVE STD.
• 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: 24531028
• Report Number: 3008021110-2026-00130
• Device Sequence Number: 8933652
• Product Code: PHX
• UDI-Device Identifier: 08033390080644
• UDI-Public: 8033390080644
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 03/06/2026

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: 1361.50.810
• Device Lot Number: 22AT144
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• 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 Age: 76 YR
• Patient Sex: Female