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 02/09/2024

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr anatomic hemi prosthesis that has taken place on (b)(6) 2024, due to cuff failure.The following components were explanted: smr humeral head ø48 mm (product code 1322.09.480, lot #1700565 - ster.1700092).Neutral adaptor taper standard (product code 1330.15.270, lot #1811423 - ster.1800266).Smr trauma humeral body # medium (product code 1350.15.010, lot #1809688 - ster.1800239).The implant was exchanged to a smr reverse prosthesis.Previous surgery took place on (b)(6) 2019.Patient's clinical details are unknown.Event happened in australia.

Manufacturer Narrative

Checking the dhrs of the involved lot #1700565, no pre-existing anomaly was found on the 64 devices manufactured with that lot #.Device analysis: devices involved were not returned to limacorporate for further analysis.No additional details were available on this event, specifically no pre-operative x-rays was available for further investigation of the adverse event.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 #1700565, and that the survivorship of the prosthesis is of 5 years, we can state that the event is not product related.Pms data: according to limacorporate pms data, the revision rate of smr humeral heads - belonging to product code 1322.09.Xxx - 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: 18739506
• MDR Text Key: 335761204
• Report Number: 3008021110-2024-00018
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.480
• Device Lot Number: 1700565
• 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