MAUDE Adverse Event Report: Limacorporate S.p.A. SMR Shoulder; Trial Revision Stem

Model Number	9013.08.156
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Intra-operative issue occurred on (b)(6) 2026 during shoulder surgery: smr-trial rev.Stem ø15mm l=180 (product code 9013.08.156, lot 15ar0h8) got stuck on the smr- humeral body impactor (product code 9013.52.140, lot 18ar065).The surgery has been performed with another instruments set took from a different hospital, causing a delay to complete the surgery (>29 minutes).No negative consequences for the patient were reported due to this issue.The patient in male, 85 years old.This event occurred in switzerland.
Additional Manufacturer Narrative
No pre-existing anomalies were detected by the check of the production documents of the lot n.Involved (15ar0h8, 18ar065).This is the first and only complaint recorded on the lot n.Involved.A final report will be submitted after the investigation.

• Brand Name: SMR Shoulder
• Common Device Name: Trial Revision Stem
• Manufacturer (Section D): Limacorporate S.p.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50711873
• Report Number: 3008021110-2026-00354
• Device Sequence Number: 10056361
• Product Code: HSD
• UDI-Device Identifier: 08033390038348
• UDI-Public: 08033390038348
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Model Number: 9013.08.156
• Device Lot Number: 15AR0H8
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown