MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.42MM

Model Number	HUMERAL HEAD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2024, due to cuff failure.The following components were explanted: smr humeral head ø42 mm (product code 1322.09.420, lot#: 1211144 - ster.1200305).Neutral adaptor taper standard (product code 1330.15.270, lot#: 1305561 - ster.1300219).Smr finned humeral body (product code 1350.15.110, lot#: 1309184 - ster.1300279).Liner for metalback glenoid small (product code 1377.50.020, lot#: 1203963 - ster.1200179).It was reported that while loosening the proximal body from the humerus with the osteotome, the humerus sustained a fracture, which was fixated with multiple fiber wire sutures.The complaint source confirmed that there wasn't any malfunction of instruments.The prosthesis was converted to reverse using a 40mm glenosphere, a connector with screw, a trauma reverse body and a short 40mm liner.Multiple microbiology specimens were taken, and a thorough washout of the wound was performed.It is unknown how long the cuff failed before the surgery took place.Primary surgery took place on (b)(6) 2014.Patient is a female, 71 years old.Event happened in new zealand.
Additional Manufacturer Narrative
Checking the manufacturing charts of involved lot#: 1211144, no pre-existing anomalies were found on the (b)(4) devices manufactured with that lot#.Device analysis: explanted components were not returned to limacorporate for investigation.Pictures of the explanted devices were shared.It is visible that the liner has worn out, however the complaint source didn't report any comment on it.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#: 1211144.It is unknown how long the cuff failed before the surgery took place.The survivorship of the prosthesis is over 10 years.We can state that the event was not product related, rather it was due to the patient's condition.Pms data: according to limacorporate pms data, the revision rate of smr anatomic prosthesis (total and hemi) 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.42MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 20448963
• Report Number: 3008021110-2024-00088
• Device Sequence Number: 20610575
• Product Code: HSD
• UDI-Device Identifier: 08033390001373
• UDI-Public: 08033390001373
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 10/09/2024

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: 1322.09.420
• Device Lot Number: 1211144
• 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: Other
• Patient Sex: Unknown