MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HUMERAL HEADS (COCRMO) - DIA.50MM H.16

Model Number	1322.09.501
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to unknown reason.Previous surgery was performed on (b)(6) 2021 when following anatomic configuration of smr system was implanted: - finned stem dia17mm l80 (pn 1304.15.270).- finned humeral body (pn 1350.15.110, lot 2110797, sterilization (b)(4)).- adaptor taper eccentrical 2mm (pn 1330.15.272, lot 2108248, sterilization (b)(4)).- humeral head dia50 h16 (pn 1322.09.501, lot 2010990, sterilization (b)(4)).- metal back glenoid std (pn 1375.21.010).- liner for metal back std (pn 1377.50.010, lot 20at5kw, sterilization (b)(4)).During revision the pre-existing finned humerla body, adaptor taper, humeral head and liner for metal back were removed and the construct was converted to a reverse configuration implanting: - reverse humeral body (pn 1352.15.010).- reverse liner +6mm (pn 1360.50.820).- connector + screw small std (pn 1374.15.310).- glenosphere eccentrical dia36 (pn 1376.09.031).Surgery was completed as intended.Patient is male, date of birth (b)(6) 1958.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing records did not higlight any pre-existing non-conformity.From follow-up communication with complaint source it was confirmed that no further information is available and no x-rays will be provided.Complaint database review did not highlight any further complaint for all batches of explanted components, thus excluding a systematic quality issue.Taking into account that: - dhr review did not highlight any anomaly, - no further events have been reported for involved lots, - conversion of the assembly from an anatomic to a reverse configuration after about 5 years from original implant suggests a possible progression of rotator cuff deficiency (even if not confirmed by complaint source), the manufacturer has no evidence to consider the event as product related.Conversion from anatomic to reverse configuration is foreseen in case of progression of patient rotator cuff insufficiency pathology and the system is indeed designed as modular platform to allow revision with a less invasive and easier surgical procedure.Based on the available pms data, the revision rate of smr humeral heads, belonging to the family product codes 1322.09.Xxx is around (b)(4).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.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) - DIA.50MM H.16
• 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: 25275483
• Report Number: 3008021110-2026-00219
• Device Sequence Number: 18581592
• Product Code: KWT
• UDI-Device Identifier: 08033390068727
• UDI-Public: 8033390068727
• Combination Product (Y/N): N
• PMA/510(K) Number: K161476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/26/2026

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: 1322.09.501
• Device Lot Number: 2010990
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• 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 Age: 67 YR
• Patient Sex: Male