MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; REVERSE HUMERAL BODY FOR ELECTIVE SURGERY

Model Number	1352.15.010
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since lot number is unknown.No x-rays nor pictures of explanted components were provided either.From follow-up communication with complaint source it was confirmed that no further information regarding the case can be retrieved, therefore no further root cause investigation is possible.Taking into account the involved product family smr shoulder, no adverse trend has been identified for reported issue in the last year.According to investigation carried out, no corrective action is needed for this event.If any additional information is received that would change or alter any conclusion, a supplemental report will be filed accordingly.The manufacturer will continue monitoring the market in order to detect any similar event.
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to pain.Previous surgery was a reverse shoulder arthroplasty in 2017, however implant record with complete product information of original assembly could not be recovered.Prosthesis was reported to have worked well for many years.Recently patient was experiencing pain.As a consequence, visit and xrays were performed and indicated lysis, possibly caused by notching or volumetric wear.Surgeon removed the pre-existing smr reverse humeral body (part number 1352.15.010), the smr reverse liner std d.40mm (part number 1365.50.810) and the smr glenosphere ø40mm small-r (part number 137409115) and implanted a new 140° humeral reverse body (part number 1352.15.015), reverse liner +3mm (part number 1360.50.815), lateralizer +2mm connector (part number 1374.15.312) and 36mm glenosphere (part number 1374.09.111).According to information provided, neither the 140° humeral body implant nor the lateralized connector were available at the time of primary surgery, otherwise surgeon would have used them for original implant.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1946.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE HUMERAL BODY FOR ELECTIVE SURGERY
• 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: 24178571
• Report Number: 3008021110-2026-00048
• Device Sequence Number: 10177572
• Product Code: PHX
• UDI-Device Identifier: 08033390272568
• UDI-Public: 8033390272568
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• 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): 01/26/2026

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: 1352.15.010
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• 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 Sex: Unknown