MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.54MM

Model Number	HUMERAL HEAD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot #0303179, no pre-existing anomaly was found on the (b)(4) devices manufactured with the same lot #.We submit a final mdr when the investigation is complete.
Event or Problem Description
Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2025, due to cuff failure, leading to eccentric loading on the poly liner and causing wear of the prosthesis.The breakage of metal back was reported but product information is not available.According to the received information, the metallosis was evident.The following components were explanted: · smr humeral head ø54 mm (product code 1322.09.540, lot #0303179 - ster.Unknown) · neutral adaptor taper standard (product code 1330.15.270, lot #0400500 - ster.Unknown) · anatomic humeral body (product code and lot # unknown) · metal back (product code and lot # unknown) · poly liner (product code and lot # unknown) · 2 bone screws (product codes and lot #s unknown) the explanted components were replaced with a new humeral body and a cta humeral head.The primary surgery took place 15 years ago, but the precise date is known.Patient is a male.It is reported he performs moderate activity level.Up to date, no further information is available.Event happened in australia.
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot #0303179, no pre-existing anomaly was found on the 20 devices manufactured with the same lot #.Device analysis.Explanted devices weren't available to be returned for investigation.X-rays analysis: it was reported that according to the surgeon responsible for the revision surgery, the reason for revision is cuff failure leading to the humeral head losing its centricity on the poly liner.Point was loading on the poly liner until failure.Limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - dated (b)(6) 2024 - and a picture of the explants have been evaluated by a medical consultant.Following, the medical consultant comments: "13 years with atsa is okay, rc failure after that time represents the fateful course of events.Radiographs with massive metallosis and failure of metalback, retrieval with massive erosion of the baseplate.All due to excentric loading which itself is due to rc failure.Although it might look like implant failure, no implant can resist the eccentric loading of rc failure induced decentering of the joint.This is not implant-related, but a natural course of events".Considering that: · check of manufacturing charts highlighted no anomalies on the devices manufactured with lot #0303179.· according to the surgeon responsible for this revision surgery, the reason for revision is cuff failure leading to the humeral head losing its centricity on the poly liner.· according to the medical consultant "13 years with atsa is okay, rc failure after that time represents the fateful course of events" and "all due to excentric loading which itself is due to rc failure".We can state that the event was not product related.Pms data: according to limacorporate pms data, the revision rate of smr anatomic total prostheses 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 final mdr.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.54MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 21502847
• Report Number: 3008021110-2025-00019
• Device Sequence Number: 17243433
• Product Code: KWT
• UDI-Device Identifier: 08033390001434
• UDI-Public: 08033390001434
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 1322.09.540
• Device Lot Number: 0303179
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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