MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø44 MM; HUMERAL HEADS (COCRMO) DIA.44MM

Model Number 1322.09.440

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

Checking the dhrs of the involved lot #1206117, no pre-existing anomaly was found on the (b)(4) manufactured with that lot # - ster.According to our records, all (b)(4) with lot #1206117 and (b)(4) have been implanted and this is the only complaint received on this lot #.Device analysis: devices involved were not returned to limacorporate for further analysis.No additional details were available on this event, specifically pre-operative x-rays weren't accessible.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that the check of manufacturing charts highlighted no anomalies on the components manufactured with the involved lot #1206117, and that the survivorship of the prosthesis is of about 12 years, we can state that the event is not product related.Pms data: according to limacorporate pms data, the revision rate of smr anatomic prosthesis (total and hemi) due to cuff failure is (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate continues monitoring the market to promptly detect any similar issue.Note: this is a combined initial-final mdr.

Event Description

Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2024, due to cuff failure.According to the received information, the cuff has failed recently in the previous few months leading up to the revision.The onset of pain is unknown however it was reported it had been present for months.The prosthesis was explanted: · smr humeral head ø44 mm (product code 1322.09.440, lot #1206117 - (b)(4)) · smr eccentric adaptor taper standard (product code 1330.15.274, lot #1207915 - (b)(4)) · smr finned humeral body (product code 1350.15.110, lot #1209412 - (b)(4)).· smr cementless finned stem (product code 1304.15.170, lot #1208125 - (b)(4)).· smr uncemented glenoid #small-r (product code 1375.20.005, lot #1211382 - (b)(4)).· liner for metalback glenoid small-r (product code 1377.50.005, lot #1208528 - (b)(4)).· bone screw ø6,5 h.20mm (product code 8420.15.010, lot #1212447 - (b)(4)).· bone screw ø6,5 h.30mm (product code 8420.15.030, lot #1212121 - (b)(4)).It was reported that wear of the liner's polyethylene was found on one posterior side of the liner and the surgeon believed the baseplate was in an inappropriate position to convert the prosthesis to reverse, therefore another company's reverse shoulder was implanted.Previous surgery took place on (b)(6) 2012.Patient is a female.No additional clinical data available.Event happened in australia.

• Brand Name: SMR HUMERAL HEAD Ø44 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.44MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 19018058
• MDR Text Key: 339084166
• Report Number: 3008021110-2024-00030
• 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
• Report Date: 04/02/2024

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: 1322.09.440
• Device Lot Number: 1206117
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• 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): Other