MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø48 MM; HUMERAL HEADS (COCRMO) DIA.48MM

Model Number 1322.09.480

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 04/02/2024

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2024, due to cuff failure.It was reported that the progressive wear of the rotator cuff required the conversion.Due to the cuff failing, the patient suffered of loss of range of motion.The prosthesis was converted from anatomic to reverse configuration explanting the following devices: · smr humeral head ø48 mm (product code 1322.09.480, lot #1915277 - ster.(b)(4)).· smr eccentric adaptor taper standard (product code 1330.15.274, lot #2200904 - ster.(b)(4)).· smr finned humeral body (product code 1350.15.110, lot #2213920 - ster.(b)(4)) · liner for metalback glenoid large (product code 1377.50.030, lot #21at2bc - ster.(b)(4)).According to the received information, the surgeon always assesses the cuff status before both primary and revision surgeries.The surgeon commented that the rotator cuff deteriorated much more quickly than expected without either contributing from the previous surgery or action of patient.It was reported that the patient had requested the anatomical option for the primary surgery.Previous surgery took place on (b)(6) 2023.Patient is a male, 75 years old.Additional clinical wasn't accessible.Event happened in australia.

Manufacturer Narrative

Checking the dhrs of the involved lot #1915277, no pre-existing anomaly was found on the 63 devices manufactured with that lot #.According to our records, at least (b)(4) humeral heads belonging to lot #1915277 and ster.(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, surgical notes, and patient's clinical detail weren't accessible.It was asked for how long the patient was suffering the loss of range of motion, however that information wasn't shared.According to the applicable instructions for use (ifus), the total anatomic shoulder replacement is recommended if the rotator cuff is intact or reconstructable.If the rotator cuff is deficient and unreconstructable, a hemiprosthesis with a cta head or a reverse shoulder arthroplasty is indicated.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 #1915277, and that the quick and progressive wear of the rotator cuff required the conversion surgery, 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.

• Brand Name: SMR HUMERAL HEAD Ø48 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.48MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 19070881
• MDR Text Key: 339711683
• Report Number: 3008021110-2024-00033
• 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: 04/09/2024

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: 1322.09.480
• Device Lot Number: 1915277
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• 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