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

Model Number 1322.09.500

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of involved lot #2204943, no pre-existing anomalies were found on the 60 components manufactured with that lot #.This is the first and only complaint received on the lot #2204943.We submit a final mdr as soon as the investigation is complete.

Event Description

Shoulder revision surgery of a hemi prosthesis performed on (b)(6), 2024, due to cuff failure.It was reported that the cuff failed on hemi for fracture, so needed to convert to reverse.The following components got explanted: smr humeral head ø50 mm (product code 1322.09.500, lot #2204943 - ster.2200110).Neutral adaptor taper standard (product code 1330.15.270, lot #2107583 - ster.2100199).Smr trauma humeral body # short (product code 1350.15.030, lot #2225834 - ster.2300014).The glenoid was prepared as per usual smr reverse, and a customized reverse humeral body was placed in, performing a lower trapezius transfer.Previous surgery was performed on (b)(6), 2023.Patient is a male, 59 years old, active.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of involved lot#: 2204943, no pre-existing anomalies were found on the (b)(4) components manufactured with that lot#.According to our records, at least 28 out of 60 humeral heads with lot#: 2204943 and ster.2200110 have been implanted and this is the only complaint received on this lot#.Explants analysis: devices involved were not returned to limacorporate for further analysis.X-rays analysis: limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - date unknown - has been evaluated by a medical consultant.Following, the medical consultant comments: "this is a clear case of post-traumatic fracture sequelae.The radiographs show the missing proximal part of the humerus with the attachments of all the rotator cuff tendons.That's why the surgeon decided for ltt in combination with rtsa and not rtsa only, as usual.The failure is trauma and disease related.There is no implant-related problem here.The hemi itself looks good".According to the applicable instructions for use (ifus), for the post-operative care the surgeon should make the patient aware of the limitations of limb function after shoulder arthroplasty and that the reconstructed joint must be protected from full load bearing for a period of time.Excessive physical activity or trauma to the replaced shoulder joint can lead to premature failure of the shoulder arthroplasty through loosening, fracture or abnormal wear of the prosthetic implants.The patient shoulder be cautioned by the surgeon to govern activities accordingly and advised that the implants may fail due to excessive joint wear.In particular the following precautions should be presented to the patient by the surgeon: avoid repeated high weight lifting; keep body weight under control; avoid sudden peak loads (consequences of activities such as contact sports, playing tennis) or movements which can lead to sudden stops or twisting; avoid positions that can increase the risk of dislocation, such as for example excessive degrees of abduction and/or internal rotation.Lack of appropriate post-operative rehabilitation instructions and care can negatively influence the outcome the surgical procedure.Considering that: check of manufacturing charts highlighted no anomalies on devices manufactured with lot#: 2204943; according to the received information, the cuff failed on hemi for fracture (the cause of the fracture is unknown); according to the medical consultant "this is a clear case of post-traumatic fracture sequelae" and "the failure is trauma and disease related.There is no implant-related problem here"; we can state that the event was not product related, rather it was patient 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 hemi prosthesis performed on (b)(6) 2024, due to cuff failure.It was reported that the cuff failed on hemi for fracture, so needed to convert to reverse.The reason for the fracture is unknown, however it was stated that it could possibly be falling onto an outstretched arm, as it is the most common form of this fracture.For the revision surgery, the surgeon asked for a customized reverse humeral body with tt side as surgeon was planning to perform a lower trapezius transfer (ltt).The following components got explanted: smr humeral head ø50 mm (product code: 1322.09.500, lot#: 2204943 - ster.2200110).Neutral adaptor taper standard (product code: 1330.15.270, lot#: 2107583 - ster.2100199).Smr trauma humeral body# short (product code: 1350.15.030, lot#: 2225834 - ster.2300014).The glenoid was prepared as per usual smr reverse, and the customized reverse humeral body was placed in.Previous surgery was performed on (b)(6) 2023.Patient is a male, 59 years old, active.Event happened in australia.

• Brand Name: SMR HUMERAL HEAD Ø50 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.50MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18826509
• MDR Text Key: 336855880
• Report Number: 3008021110-2024-00022
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.500
• Device Lot Number: 2204943
• 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