MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SYSTEM; SMR HUMERAL HEAD Ø52 MM

Catalog Number	1322.09.520
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the dhrs of the involved lot #1802753 (ster.#(b)(4)), no pre-existing anomaly was found on (b)(4) devices manufactured with that lot and ster.According to our records this is the only complaint received on this lot # and ster.#.This is initial mdr report the manufacturer will submit a final mdr report when the investigations are closed.
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due cuff failure.The following smr stemless anatomic implants were removed and reverse from stryker was implanted: · smr humeral head ø52 mm (product code 1322.09.520, lot # 1802753 - ster.(b)(4)) sold in us.· smr stemless - neutral adaptor (product code 1335.15.200, lot # 1713952 - ster.(b)(4)) sold in us.· smr stemless - steml.Core #m (product code 1355.14.235, lot # 1714291 - ster.(b)(4)) sold in us · cemented glenoid 3 pegs small (product code 1379.51.020, lot # 15at1pg - ster.(b)(4)) previous surgery was perfromed on (b)(6) 2018.Patient is a male, 67 years old.Event happened in australia.
Additional Manufacturer Narrative
A review of the device history records and sterilization documentation was performed for the involved lot: · lot #1802753 (ster.#(b)(4)): no anomalies, deviations, or nonconformities were identified during manufacturing or sterilization.A total of (b)(4) devices were manufactured and sterilized under this lot.According to limacorporate records, this represents the first and only complaint received for the involved lot and sterilization number.Device analysis the explanted devices were not returned to limacorporate for further physical analysis.However, pre-revision x-rays and photographs of the explanted devices were provided by the complaint source.This documentation was reviewed internally and subsequently shared with a medical expert for a clinical assessment of the event.The expert's evaluation states: "the case is a rotator cuff failure.There is no sign for implant related failure.It is a fateful course of events." based on the available radiographic documentation and the medical expert's assessment, no evidence suggestive of implant malfunction, material failure, or design-related issues was identified.Considering that the exact root cause of the event cannot be conclusively determined due to the limited clinical and technical information available and the absence of the explanted devices for physical examination, based on the following considerations: · the review of the device history records and sterilization documentation for the involved lot and sterilization number did not identify any anomalies or nonconformities.· this is the first and only complaint reported for the involved lot and sterilization #; · the medical expert assessment did not identify any implant-related failure and attributed the event primarily to rotator cuff failure.· no additional clinical, radiographic, or technical data are available to support further investigation.The event is assessed as not product-related.Pms data: 4 similar events from 9 units sold in australia (b)(4) in the past 3 years.8 similar events from (b)(4) units sold worldwide (b)(4) in the past 3 years.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate continues monitoring the market to promptly detect any further similar issue.This is final mdr report.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR HUMERAL HEAD Ø52 MM
• 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: 23345068
• Report Number: 3008021110-2025-00143
• Device Sequence Number: 9470763
• Product Code: KWT
• UDI-Device Identifier: 08033390274296
• UDI-Public: 08033390274296
• Combination Product (Y/N): Y
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/20/2025

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 Catalogue Number: 1322.09.520
• Device Lot Number: 1802753
• 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: 10/21/2025
• Supplement Report FDA Received Date: 01/19/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown