MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø50 MM; SMR SHOULDER SYSTEM - HUMERAL HEADS (COCRMO) DIA.50MM

Model Number 1322.09.500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 02/14/2024

Event Type  Injury  

Event Description

Shoulder revision surgery performed on (b)(6) 2024 due to rotator-cuff failure.The smr anatomic implant, originally implanted on (b)(6) 2023, was revised with a smr reverse prosthesis.During the revision surgery the following components have been explanted: - smr humeral head ø50 mm (commercial code 1322.09.500, lot 2208669, sterilization number 2200148) - neutral adaptor taper standard (commercial code 1330.15.270, lot 2220567, sterilization number 2200318) - smr finned humeral body (commercial code 1350.15.110, lot 2319417, sterilization number 2300208) - liner f.Met.Back glen.Standard (commercial code 1377.50.010, lot 22at0lx, sterilization number 2200132) they have been replaced with the following new components: - smr shoulder glenosphere (commercial code 1376.09.041, lot 2330227, sterilization number 2400010) - smr connector small + screw (commercial code 1374.15.322, lot 2310185, sterilization number 2300124) - smr reverse humeral body (commercial code 1352.15.010, lot 2327566, sterilization number 2300282) - smr reverse liner (commercial code 1365.50.815, lot 23at1k7, sterilization number 2300195).The patient is a male, date of birth (b)(6) 1965.Event happened in united states.

Manufacturer Narrative

Investigation checking the manufacturing charts of the lot numbers involved, no pre-existing anomaly that could have contributed to the event has been found out.According to the data available, at least 17 out of 26 liners f.Met.Back glen.Standard belonging to the lot number 22at0lx and sterilization number 2200132, have been implanted, and this is the first and only complaint received for this lot.Neither x-rays nor explanted components were available for further analysis.According to the information received by the complaint source, the event was due to the patient condition (however we did not receive any other clinical detail regarding the patient).Therefore, we can conclude that the event was not product related.Pms data according to the relevant pms data, the occurrence rate of revision surgeries of liner f.Met.Back glen.Standard, belonging to the family codes 1377.50.Xxx, due to rotator cuff failure is around 0.1%.Based on the root cause analysis performed, no corrective action is needed for this specific case.Limacorporate will continue monitoring the market to promptly detect further similar issues.Note: this is a combined initial-final mdr.

Event Description

Shoulder revision surgery performed on (b)(6),2024 due to rotator-cuff failure.The smr anatomic implant, originally implanted on (b)(6) 2023, was revised with a smr reverse prosthesis.During the revision surgery the following components have been explanted: smr humeral head ø50 mm (commercial code 1322.09.500, lot 2208669, sterilization number 2200148) neutral adaptor taper standard (commercial code 1330.15.270, lot 2220567, sterilization number 2200318) smr finned humeral body (commercial code 1350.15.110, lot 2319417, sterilization number 2300208) liner f.Met.Back glen.Standard (commercial code 1377.50.010, lot 22at0lx, sterilization number 2200132) they have been replaced with the following new components: smr shoulder glenosphere (commercial code 1376.09.041, lot 2330227, sterilization number 2400010) smr connector small + screw (commercial code 1374.15.322, lot 2310185, sterilization number 2300124) smr reverse humeral body (commercial code 1352.15.010, lot 2327566, sterilization number 2300282) smr reverse liner (commercial code 1365.50.815, lot 23at1k7, sterilization number 2300195).The patient is a male, date of birth (b)(6) 1965.Event happened in united states.

Manufacturer Narrative

Investigation after the accurate review of the information received by the complaint source, we established that the suspected product is the smr humeral head ø50 mm, not the liner f.Met.Back glen.Standard, as documented in the previous report.Therefore, with this follow-up report, we are updating our investigation accordingly.Checking the manufacturing charts of the lot number involved, no pre-existing anomaly that could have contributed to the event has been found out.According to the data available, at least 34 out of 62 smr humeral heads belonging to the lot number 2208669 and sterilization number 2200148, have been implanted, and this is the first and only complaint received for this lot.Neither x-rays nor explanted components were available for further analysis.According to the information received by the complaint source, the event was due to the patient condition (however we did not receive any other clinical detail regarding the patient).Therefore, we can conclude that the event was not product related.Pms data according to the relevant pms data, the occurrence rate of revision surgeries of smr humeral head ø50 mm, belonging to the family codes 1322.09.Xxx, due to rotator cuff failure is around 0.37%.Based on the root cause analysis performed, no corrective action is needed for this specific case.Limacorporate will continue monitoring the market to promptly detect further similar issues.

• Brand Name: SMR HUMERAL HEAD Ø50 MM
• Type of Device: SMR SHOULDER SYSTEM - HUMERAL HEADS (COCRMO) DIA.50MM
• 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: 18873366
• MDR Text Key: 337294659
• Report Number: 3008021110-2024-00020
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.500
• Device Lot Number: 2208669
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention