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

Model Number	1360.50.810
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to septic loosening performed on (b)(6) 2025.Patient complained of pain and x-rays were taken.It was determined that the stem appeared loose a due to a possible infection.A 1st stage infection surgery was scheduled.The following components were removed: - smr cementless finned stem (part number 1304.15.180, lot number 1808774, sterilization (b)(4)) - smr reverse humeral body (part number 1352.15.010, lot number 1809657, sterilization (b)(4)) - smr reverse liner standard (part number 1360.50.810, lot number 18at0gk, sterilization (b)(4)) - smr glenosphere ø36 mm (part number 1376.09.030, lot number 1809534, sterilization (b)(4)).The lima long revision stem was trialed along with multiple extensions and liners.It was determined that this combination would not reduce properly.A tornier revision stem was trialed along with various trays and liners.It was determined that this was a good fit and the definitive implants were implanted along with a lima 36 eccentric glenosphere.Previous surgery took place on (b)(6) 2018.The patient is a female, date of birth (b)(6) 1964.The event happened in the united states.
Additional Manufacturer Narrative
No pre-existing anomaly was detected by checking the manufacturing and sterilization charts of the lot numbers involved in the event.We will submit a final report as soon as the investigation is complete.
Additional Manufacturer Narrative
Investigation: no pre-existing anomaly was detected by checking the manufacturing and sterilization charts of the lot numbers involved in the event.This is the first and only complaint received on these lot numbers.Neither x-rays nor removed components were available to be shared with the manufacturer.Therefore we are not able to carry out additional investigation on this event.However, we have been informed by the complaint source that the revision surgery has been completed by removing all the components previously implanted, replacing them with a glenosphere (part code 1376.09.031) and a connector (part code 1374.15.310) combined with a third-part humeral stem.Hence, considering that: - no pre-existing anomalies were discovered by checking the manufacturing and sterilization charts of the devices involved in the event hereby reported - this is the only complaints received in these lot numbers.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 codes 1360.50.Xxx, 1361.50.Xxx and 1365.50.Xxx due to infection is around 0.06%.According to the investigation carried out, no corrective action is needed for this event.The manufactured will continue monitoring the market in order to detect any similar events.Note: this is a final mdr.
Event or Problem Description
Revision surgery due to septic loosening performed on (b)(6) 2025.Patient complained of pain and x-rays were taken.It was determined that the stem appeared loose due to a possible infection.A 1st stage infection surgery was scheduled.The following components were removed: - smr cementless finned stem (part number 1304.15.180, lot number 1808774, sterilization (b)(4)).- smr reverse humeral body (part number 1352.15.010, lot number 1809657, sterilization (b)(4)).- smr reverse liner standard (part number 1360.50.810, lot number 18at0gk, sterilization (b)(4)).- smr glenosphere ø36 mm (part number 1376.09.030, lot number 1809534, sterilization (b)(4)) the lima long revision stem was trialed along with multiple extensions and liners.It was determined that this combination did not reduce properly.A tornier revision stem was trialed along with various trays and liners.It was determined that this was a good fit and the definitive implants were implanted along with a lima 36 eccentric glenosphere.Previous surgery took place on (b)(6) 2018.The patient is a female, date of birth (b)(6) 1964.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: 21362127
• Report Number: 3008021110-2025-00003
• Device Sequence Number: 20941248
• Product Code: PHX
• UDI-Device Identifier: 08033390080613
• UDI-Public: 8033390080613
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 11/24/2025

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: 18AT0GK
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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