MAUDE Adverse Event Report: LIMACORPORATE SPA SMR HUMERAL HEAD Ø46 MM; SMR HUMERAL HEAD Ø46 MM (KWT, HSD)

Model Number 1322.09.460

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

Check of the dhrs: by checking the dhrs of the lots involved, no anomaly was found on a total of 66 humeral heads manufactured with lot #1703637.Moreover, according to our traceability records, a total of 49 out of 66 hum.Heads manufactured with the same lot# were yet implanted without received additional complaints.Explants analysis: explants not available for investigation as they have been discarded by the hospital.Xrays analysis: we received some pre-operative x-rays referring to the revision surgery (exact date unknown) and sent them to our medical consultant for a clinical evaluation.Following, his opinion based on the few information available: "while it is difficult to be accurate with the imaging available, the sense i have is that the humeral component is markedly retroverted.If that is so that will be the main cause of the dislocation.I am unable to see a greater tuberosity but i will assume at the index procedure the cuff was intact.I am also unable to comment on the version of the glenoid but on the images available i am unable to see any obvious abnormality.In summary i think the cause of the instability is abnormal humeral retroversion.I.E.Surgical error." conclusion: based on the check of the dhrs and on the analysis performed by our medical consultant, we can conclude that likely cause for the instability/dislocation reported was related to a surgical error during the first implant (abnormal humeral retroversion).Case not product related.Pms data: by linking the total number of revision surgeries lima is aware of about smr anatomic prosthesis dislocation and the total number of smr anatomic prosthesis sold ww (40000+), we can estimate a specific revision rate of 0.50%.Based on the info reported, more than 75% of these cases were related to cuff failure, patient condition or surgical factor.According to the complaints investigated, none of the events reported were product related.No specific corrective action for this case.Lima corporate will continue monitoring the market to promptly detect any future similar issue.Please, consider this report as a final mdr.

Event Description

Revision surgery of a smr anatomic total prosthesis due to chronic dislocation occurred on (b)(6) 2019 with conversion to reverse.Primary surgery occurred on (b)(6) 2018.It was reported that posterior capsule was deficient.No other info available.Event occurred in (b)(6).

• Brand Name: SMR HUMERAL HEAD Ø46 MM
• Type of Device: SMR HUMERAL HEAD Ø46 MM (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8699662
• MDR Text Key: 148161401
• Report Number: 3008021110-2019-00070
• 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
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1322.09.460
• Device Lot Number: 1703637
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention