MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.52MM

Model Number	HUMERAL HEAD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery of a smr stemless anatomic prosthesis performed on (b)(6) 2024, due to cuff failure.The patient had a cuff tear and surgeon did a conversion anatomic to reverse with the hybrid baseplate.The following components were explanted: smr humeral head ø52 mm (product code 1322.09.520, lot #1919682 - ster.(b)(4)).Smr stemless - 2mm ecc.Adaptor (product code 1335.15.202, lot #1807915 - ster.(b)(4)).Tt hybrid cemented glenoid small (product code 1379.59.110, lot #2004267 - ster.(b)(4)).A tt hybrid reverse baseplate small, two bone screws, a reverse hp glenosphere 40mm and a reverse liner for stemless core #long 40mm were implanted.Primary surgery took place on (b)(6) 2022.Patient is a male, 63 years old.Event happened in australia.
Additional Manufacturer Narrative
Checking the manufacturing charts of involved lot #1919682, no pre-existing anomalies were found on the (b)(4) devices manufactured with the same lot #.According to our records, at least (b)(4) out of (b)(4) devices manufactured with lot #1919682 and ster.(b)(4) have been implanted and this is the only complaint received on that lot #.Device analysis: explanted components were not returned to limacorporate for investigation.No additional details were available on this post-operative issue, specifically pre-operative x-rays related to the revision surgery were not accessible.Based on the few information received we are not able to further investigate the root cause of the event, however considering that: check of manufacturing charts highlighted no anomalies on components manufactured with lot #1919682; the survivorship of the prosthesis is of 2 years; we can state that the event was not product related.Pms data: according to limacorporate pms data, the revision rate of smr anatomic stemless prosthesis 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 SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.52MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 20448966
• Report Number: 3008021110-2024-00092
• Device Sequence Number: 17919743
• Product Code: KWT
• UDI-Device Identifier: 08033390001427
• UDI-Public: 08033390001427
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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: HUMERAL HEAD
• Device Catalogue Number: 1322.09.520
• Device Lot Number: 1919682
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown