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 Code	Muscle/Tendon Damage (4532)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot#: 1412462, no pre-existing anomaly was found on the (b)(4) devices manufactured with the same lot#.According to our records, all 58 humeral heads with lot#: 1412462 and ster.1500006 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.A picture of the explanted devices was shared: it is observed on it that the explanted l1 liner is worn on one side.It was reported by the complaint source that according to the surgeon, the cuff failure was the cause of the liner wear.X-rays analysis: limacorporate received a total of 2 x-rays referring to pre-operative revision surgery.The x-rays received - dated on (b)(6) 2024 - and the picture of the explanted devices have been evaluated by a medical consultant.Following, the medical consultant comments: "this is a typical case of an age-dependent rc failure and resulting antero-superior escape of the prosthesis.There is no sign for implant related failure.This is a fateful course of events".Considering that: check of manufacturing charts highlighted no anomalies on the devices manufactured with lot#: 1412462.The prosthesis has a survivorship of over 9 years.According to the medical consultant "this is a typical case of an age-dependent rc failure and resulting antero-superior escape of the prosthesis.There is no sign for implant related failure".We can state that the event was not product related.Pms data: according to limacorporate pms data, revision rate of smr anatomic 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.
Event or Problem Description
Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2024, due to cuff failure.It was reported that a conversion from anatomical to reverse was performed.The following devices got explanted: smr humeral head ø44 mm (product code: 1322.09.440, lot#: 1412462 - ster.1500006).Neutral adaptor taper standard (product code: 1330.15.270, lot#: 1411227 - ster.1400321).Smr finned humeral body (product code: 1350.15.110, lot#: 1414868 - ster.1500036).Liner for metalback glenoid standard (product code: 1377.50.010, lot#: 1407634 - ster.1400232).The surgeon was satisfied with the final stability and range of motion.Previous surgery took place on (b)(6) 2015.Patient is a male, 68 years old.No comorbidities were reported.Event happened in australia.
Event or Problem Description
Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2024, due to cuff failure.It was reported that a conversion from anatomical to reverse was performed.The following devices got explanted: smr humeral head ø44 mm (product code: 1322.09.440, lot#: 1412462 - ster.1500006).Neutral adaptor taper standard (product code: 1330.15.270, lot#: 1411227 - ster.1400321).Smr finned humeral body (product code: 1350.15.110, lot#: 1414868 - ster.1500036).Liner for metalback glenoid standard (product code: 1377.50.010, lot#: 1407634 - ster.1400232).The surgeon was satisfied with the final stability and range of motion.Previous surgery took place on (b)(6) 2015.Patient is a male, 68 years old.No comorbidities were reported.Event happened in australia.
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lots#: 1412462, no pre-existing anomaly was found on the 58 devices manufactured with the same lot#.This is the first and only complaint received on that lot#.We submit a final mdr when the investigation is complete.

• 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: 21091069
• Report Number: 3008021110-2024-00107
• Device Sequence Number: 9171774
• 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: 2015
• 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,Followup
• Report Date (Section B): 12/09/2024

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: 1412462
• 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: 01/07/2025
• Supplement Report FDA Received Date: 01/07/2025
• 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: Other
• Patient Sex: Unknown