MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.42MM

Model Number	1322.09.420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to rotator cuff tear performed on (b)(6) 2025.The implants were replaced by reverse and the following components were removed: liner f.Met.Back glen.Small-r (part code 1377.50.005, lot number 20at1h5, sterilization (b)(4), smr humeral head dia.42 mm (part code 1322.09.420, lot number 2000676, sterilization (b)(4), smr ecc.Adaptor taper standard (part code 1330.15.274, lot number 2005237, sterilization (b)(4), smr trauma hum.Body # short (part code 1350.15.030, lot number 1700882, sterilization (b)(4).The glenoid components (smr glenoid peg tt small-r #s - part code 1375.14.651, and smr glenoid baseplate small-r - part code 1375.15.605) were left in situ.Previous surgery took place on (b)(6) 2022.The patient is a female, date of birth (b)(6) 1945.The event happened in the united states.
Additional Manufacturer Narrative
Investigation checking the manufacturing charts of the smr humeral head dia.42 mm with part code 1322.09.420, no pre-existing anomaly was found on the 72 items belonging to the lot number 2000676 and sterilization (b)(4).Neither removed components, nor radiographs were available to be shared with the manufacturer.Therefore, we are not able to carry out any further investigation.However, taking into account that: checking the manufacturing charts of the smr humeral head that belongs to the part code 1322.09.420, lot number 2000676 and sterilization (b)(4), no pre-existing anomaly was found in the items with the same part code and lot no further information about the causes of the rotator cuff tear was provided by the complaint source.We have no evidence to consider the event as product related.Pms data according to pms data, the revision rate of smr anatomic prosthesis (total and hemi) due to cuff failure is around (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.The manufacturer continues monitoring the market to promptly detect any similar issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.42MM
• 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: 22288037
• Report Number: 3008021110-2025-00075
• Device Sequence Number: 8893442
• Product Code: KWT
• UDI-Device Identifier: 08033390001373
• UDI-Public: 08033390001373
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/18/2025

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: 1322.09.420
• Device Lot Number: 2000676
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• 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