MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.44MM

Model Number	HUMERAL HEAD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery of a smr stemless anatomic implant performed on (b)(6) 2024, due to cuff failure.The cuff failed approximately 4 years post the primary surgery.The hybrid poly was removed, leaving the peg in situ, the humeral head and the adaptor were explanted: smr humeral head ø44 mm (product code: 1322.09.440, lot#: 1905765 - ster.1900200).Smr stemless - 2mm eccentrical adaptor (product code: 1335.15.202, lot#: 1816780 - ster.1800383).· tt hybrid cemented glenoid #s low+2 (product code: 1379.59.102, lot#: 1907961 - ster.1900214).The implant was converted to reverse configuration using a hybrid reverse baseplate with two screws, a glenosphere and a reverse liner.The stemless core was left in situ.Patient's clinical details are unknown.Primary surgery took place on (b)(6) 2019.Event happened in (b)(6).
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot#: 1905765, no pre-existing anomaly was found on the (b)(4) devices manufactured with the same lot#.According to our records, at least 56 out of 68 humeral heads with lot#: 1905765 and ster.1900200 have been implanted and this is the only complaint received on this lot#.Device analysis: devices involved are not returning to limacorporate for further analysis.No additional details were available on this post-operative issue, specifically pre-operative x-rays related to the revision surgery were asked, but not available.Based on the very 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 the involved lot#: 1905765.The cuff failed approximately 4 years post the primary implant.We cannot define the root cause of the event, but we can state that it was not product related.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 are required for this specific case.Limacorporate continues monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.44MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 21136184
• Report Number: 3008021110-2024-00101
• Device Sequence Number: 6825342
• Product Code: KWT
• UDI-Device Identifier: 08033390001380
• UDI-Public: 08033390001380
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/19/2024

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: 1322.09.440
• Device Lot Number: 1905765
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2025
• 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