MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR-FLATTENED HUMERAL HEAD D.52MM; HUMERAL HEADS (COCRMO) - DIA.52MM H.17

Model Number 1322.09.521

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lots involved, no pre-existing anomaly was detected.This is the first and only complaint received on these lots.We will submit a final mdr once the investigation will be completed.

Event Description

Conversion of smr stemless anatomic system to stemless reverse due to cuff failure performed on (b)(6) 2020.Primary surgery was performed on (b)(6) 2018.According to the information reported, surgeon believed that root cause for cuff failure was tt metal back implanted tilted up; however, he did not replaced it because well fixed.The following components were explanted: smr humeral head d.54 h.18mm product code 1322.09.541 lot#1705800 ster.1700187 smr glenoid baseplate standard product code 1375.15.610 lot#1803720 ster.1800135 patient was male, (b)(6) years old.Event occurred in (b)(6).

Manufacturer Narrative

Manufacturing records were checked confirming that the involved lots #1706511, #1610390, #1714987 and #17at0ue were manufactured correctly up to specification and in-line with the relevant checks and tests.No manufacturing deviations were reported.The items involved were not available to be returned to limacorporate for further analysis.X-rays analysis limacorporate received one x-ray referring to pre-op revision surgery.The x-ray received - exact date not known - has been evaluated by a medical consultant.Following, the medical consultant comments: "the implant has survived just two years before the revision surgery and likely will have failed before that time obviously.It is very difficult with the cropped image to make more than a "speculation", but i have the sense that the inclination of the glenoid prosthesis is upwards and if that is so, it is likely a significant cause of the cuff failure and a surgeon error.The position within the glenoid vault otherwise is ideal for an anatomical tsa.The stemless humeral component is i think the correct size and the inclination (head angle) is satisfactory at approximately 120 degrees.What i am unable to comment on is the pre-2018 status of the cuff and the immediate post-op status of the cuff.There is no mention of any concern and therefore we must assume it (the cuff) was satisfactory.In summary the only remarkable feature is the upwards inclination of the glenoid component which as described is a significant factor in the failure of the cuff as well as other failures".Based on the received information, we can state that: check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with the same lot #s of the involved devices; according to the medical consultant "the only remarkable feature is the upwards inclination of the glenoid component which as described is a significant factor in the failure of the cuff as well as other failures"; we can state that the event was mostly surgical factor related.Pms data according to limacorporate pms data, revision surgeries due to cuff failure involving shoulder anatomic implants with humeral heads - belonging to product codes 1321/1322/1324/1325.09/15.Xxx - we estimate a revision rate of (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 will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Conversion of smr stemless anatomic system to stemless reverse performed on (b)(6) 2020 due to cuff failure.According to the information reported, surgeon believed that root cause for cuff failure was the smr glenoid baseplate standard (product code 1375.15.610, lot #1706511 - ster.1700210) implanted tilted up; however, this component was not replaced it because was well fixed.The following components were explanted: smr-flattened humeral head d.52mm (product code 1322.09.521, lot #1610390 - ster.1600199).Smr stemless - neutral adaptor (product code 1335.15.200, lot #1714987 - ster.1800030) - product not sold in the us.Liner for metal back std (product code 1377.50.010, lot #17at0ue - ster.1700226).Primary surgery was performed on (b)(6) 2018.Patient is a male, 60 years old.Event occurred in new zealand.Note: in respect to the initial report, we became aware of the correct lot #s of the involved humeral head, glenoid baseplate, neutral adaptor and liner.Product code and lot # of the suspected component have been exchanged to the correct ones.The shoulder stemless system is not cleared in the us.The event is reported as the suspected component is the humeral head, also available in the smr anatomic system.

• Brand Name: SMR-FLATTENED HUMERAL HEAD D.52MM
• Type of Device: HUMERAL HEADS (COCRMO) - DIA.52MM H.17
• Manufacturer (Section D): LIMACORPORATE S.P.A.; 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: 10157855
• MDR Text Key: 199844558
• Report Number: 3008021110-2020-00042
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K161476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

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: 1322.09.521
• Device Lot Number: 1610390
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 12/29/2021
• 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): Required Intervention