MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD D.50 H.21MM; HUMERAL HEADS (COCRMO) - DIA.50MM H.21

Model Number 1324.09.501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

Checking the dhrs of the involved lot #1923285, no pre-existing anomaly was found on the 6 devices manufactured with that lot #.This is the only complaint received on that lot #.Checking the sterilization charts of involved lot #s, no pre-existing anomaly was found on the overall number.Therefore, products with those lot #s have been properly sterilized before being placed on the market.Device analysis devices involved were not returned to limacorporate for further analysis.X-rays analysis limacorporate received one x-ray referring to pre-operative of the revision surgery.The x-ray received - taken within 7 days of the revision surgery - and two pictures of the explanted devices have been evaluated by a medical consultant.Following, the medical consultant comments: "there is some wear of the pe liner, but this is normal, running in of the prosthesis.The humeral head position seems to be suboptimal to me, a little bit of overstuffing.This might have contributed to cuff failure.I guess this is a mix of cuff failure in a 76y old patient with low-grade infection.There is no sign for implant related failure here".Considering that: · check of manufacturing charts highlighted no anomalies on the components manufactured with lot #1923285; · according to the received information, there was some evidence of low-grade infection; · check of sterilization charts found no pre-existing anomalies on the involved lot #s; · according to the medical consultant "[.] the humeral head position seems to be suboptimal to me, a little bit of overstuffing.This might have contributed to cuff failure.I guess this is a mix of cuff failure in a 76y old patient with low-grade infection.There is no sign for implant related failure here"; we can state that the event was 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.

Event Description

Shoulder revision surgery of a smr anatomic total prosthesis that has taken place on (b)(6) 2023, due to cuff failure.Surgeon stated the cuff had failed but that there was some evidence of low-grade infection.Swabs were taken to the lab, but results are yet not available.The following components were removed: · smr humeral head d.50 h.21mm (product code 1324.09.501, lot #1923285 - (b)(4)) · smr eccentric adaptor taper standard (product code 1330.15.272, lot #2116690 - (b)(4)) · smr finned humeral body (product code 1350.15.110, lot #2122345 - (b)(4)) · liner for metalback glenoid standard (product code 1377.50.010, lot #20at5kx - (b)(4)).The prosthesis got converted to smr reverse.Previous surgery took place on (b)(6) 2022.Patient is a male, 76 years old.Bmi of 20.Event happened in australia.

• Brand Name: SMR HUMERAL HEAD D.50 H.21MM
• Type of Device: HUMERAL HEADS (COCRMO) - DIA.50MM H.21
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18683527
• MDR Text Key: 335071146
• Report Number: 3008021110-2024-00011
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K161476
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1324.09.501
• Device Lot Number: 1923285
• 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