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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)

Event Date 02/06/2024

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr anatomic total prosthesis that has taken place on february 6th, 2024, due to cuff failure.It was reported that the patient had a degenerative cuff resulting in loss of range of motion and increased pain.The following components were explanted: · smr humeral head ø48 mm (product code 1322.09.480, lot #1503492 - ster.1500145) · smr eccentric adaptor taper standard (product code 1330.15.272, lot #1412090 - ster.1500012) · smr finned humeral body (product code 1350.15.110, lot #1505595 - ster.1500137) · smr metalback liner 6mm small-r (product code 1377.50.006, lot #1308323 - ster.1300245) it was reported that the cuff started degenerating from a significant period of time, but it was unsure from how long.A conversion from smr anatomic total to smr reverse was undertaken.Previous surgery took place on (b)(6) 2015.Patient is a female, 79 years old.Bmi of 22.According to the received information, she had the other shoulder side converted in (b)(6) 2023 and it was commented that this side should have been revised in 2024.Event happened in australia.

Manufacturer Narrative

Checking the dhrs of the involved lot #1503492, no pre-existing anomaly was found on the 64 devices manufactured with that lot #.According to our records, at least 56 out of 64 humeral heads with lot #1503492 and ster.1500145 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 were asked to the complaint source but weren't available.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 #1503492, and that the survivorship of the prosthesis is of about 9 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 due to cuff failure is 0.63%.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: 18710516
• MDR Text Key: 335463954
• Report Number: 3008021110-2024-00016
• 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: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.480
• Device Lot Number: 1503492
• 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