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

Model Number 1322.09.520

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

By checking the manufacturing charts of the involved lot#, no pre-existing anomaly was found on a total of 60 smr humeral heads manufactured with the same lot#.According to our records, at least 8 out of 60 humeral heads with lot #2010293 - ster.2000244 have been implanted and this is the only complaint received on this lot #.Limacorporate received a picture of the explants and a total of two x-rays referring to pre-op revision surgery.The x-rays received - dated (b)(6) 2021 - have been evaluated by a lima medical consultant.Following, the medical consultant comments: "i suspect a rotator cuff failure (subscap) after the revision as the cause for dislocation.This is the most common problem.This is patient-related (maybe procedure-related, but that is speculative) and not implant-related in my opinion".Stating that: no anomalies were found by checking the manufacturing charts of the involved lot number; according to the medical consultant statement, cause of the revision is likely to be patient related; the surgeon responsible for the revision surgery stated that soft tissues could have been better balanced during the previous surgery and that, at that time, a reverse shoulder prosthesis would have been preferable we can state that the event is not product related.Pms data we are aware of a total of 22 conversion cases of smr anatomic total to smr reverse prosthesis due to dislocation/luxation on a total of 46234 smr anatomic total implants performed ww leading to a rate of 0,05%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final report.

Event Description

Conversion surgery from smr anatomic to smr reverse prosthesis performed on (b)(6) 2021, due to dislocation/luxation of the smr humeral head ø52 mm (product code 1322.09.520, lot #2010293 - ster.2000244).According to the reported information, previous surgery was performed on (b)(6) 2021, in which a competitor's prosthesis was explanted and replaced by a smr anatomic prosthesis.It was reported that the patient dislocated the following day, whereby the surgeon realized that balancing the soft tissue after a removal was problematic as illustrated by the very early dislocation.During the revision surgery, the following components were explanted: smr humeral head ø52 mm (product code 1322.09.520, lot #2010293 - ster.2000244).Neutral adaptor taper standard (product code 1330.15.270, lot #2008551 - ster.2000240).· smr trauma humeral body # long (product code 1350.15.020, lot #2010256 - ster.2000240) liner for metal back glenoid standard (product code 1377.50.010, lot #20at0lz - ster.2000229).According to the complaint source, surgeon commented that maybe the original revision should have been straight to a reverse prosthesis.Patient is a male.Event happened in (b)(6).

• Brand Name: SMR HUMERAL HEAD 52 MM
• Type of Device: 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: 12007722
• MDR Text Key: 267898704
• Report Number: 3008021110-2021-00043
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1322.09.520
• Device Lot Number: 2010293
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other