MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø50 MM; HUMERAL HEADS (COCRMO) DIA.50MM

Model Number 1322.09.500

Device Problem Material Erosion (1214)

Patient Problem Failure of Implant (1924)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts of the involved lots #1206118 and #1303539, no pre-existing anomaly was found on the components manufactured with the same lot #s.We submit a final mdr as soon as the investigation is completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2022, due to wear of the components.In details, the smr humeral head ø50 mm (product code 1322.09.500, lot #1206118 - ster.1200207) has worn away the top part of the liner for metal back glenoid standard (product code 1377.50.010, lot #1303539 - ster.1300139) and of the baseplate.The following components were explanted: smr humeral head ø50 mm (product code 1322.09.500, lot #1206118 - ster.1200207).Liner for metal back glenoid standard (product code 1377.50.010, lot #1303539 - ster.1300139).Smr uncemented glenoid # std (product code 1375.20.010, lot #1304767 - ster.1300181).Smr eccentric adaptor taper standard (product code 1330.15.274, lot #1301893 - ster.1300107).Smr finned humeral body (product code 1350.15.110, lot #1304139 - ster.1300181) it was reported that there were signs of metallosis.The implant was converted to reverse.Previous surgery took place on (b)(6) 2013.Event happened in new zealand.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1206118, no pre-existing anomaly was found on a total of 24 items manufactured with the same lot #.Checking the manufacturing charts of the involved lot #1303539, no pre-existing anomaly was found on a total of 14 items manufactured with the same lot #.According to our records, at least 13 out 14 glenoid liners with lot #1303539 - ster.1300139 have been implanted and this is the only complaint received on this lot #.Explants analysis: 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-operative revision surgery.The x-ray received - exact date not known - has been evaluated by a medical consultant.Following, the medical consultant comments: "the humeral side looks well implanted, good size and position of the components.With the glenoid side it is hard to tell on this radiograph.There is some radiolucency under the humeral head, but this is probably related to stress shielding; infection cannot be ruled out completely.The implant was in place for 11 years.Rotator cuff failure is the most common reason for revision of primary tsa over time in most of the studies and registries.This is the most likely reason for failure here and it lead to superior migration of the humeral component that subsequently lead to edge loading, asymmetrical wear of the pe liner.In summary this case probably reflects a very common mechanism of need for revision of tsa.Eleven-year implant survival is below the mean survival in most studies and registries, but survival over time represents a gauss distribution and somebody has to be at the lower end to make it a normal distribution.I cannot see any implant related problems here".Considering that: check of the manufacturing charts highlighted no anomalies on the components manufactured with lots #1206118 and #1303539; the prosthesis has been in place for 9 years; according to the medical consultant "there is some radiolucency under the humeral head, but this is probably related to stress shielding; infection cannot be ruled out completely" and "rotator cuff failure is the most common reason for revision of primary tsa over time in most of the studies and registries".In addition, the consultant commented that "i cannot see any implant related problems here"; we can state that the event was not product related.Pms data: according to limacorporate pms data, the revision rate of smr humeral head ø50 mm - belonging to the family codes 1322.09.Xxx - due to wear is 0.01%.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

Shoulder revision surgery performed on (b)(6) 2022, due to wear of the components.In details, the smr humeral head ø50 mm (product code 1322.09.500, lot #1206118 - ster.1200207) has worn away the top part of the liner for metal back glenoid standard (product code 1377.50.010, lot #1303539 - ster.1300139) and of the baseplate.The following components were explanted: smr humeral head ø50 mm (product code 1322.09.500, lot #1206118 - ster.1200207).Liner for metal back glenoid standard (product code 1377.50.010, lot #1303539 - ster.1300139).Smr uncemented glenoid # std (product code 1375.20.010, lot #1304767 - ster.1300181) - product not sold in the us.Smr eccentric adaptor taper standard (product code 1330.15.274, lot #1301893 - ster.1300107).Smr finned humeral body (product code 1350.15.110, lot #1304139 - ster.1300181) it was reported that there were signs of metallosis.The implant was converted to reverse.Previous surgery took place on (b)(6) 2013.Event happened in new zealand.

• Brand Name: SMR HUMERAL HEAD Ø50 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.50MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 15649287
• MDR Text Key: 302168064
• Report Number: 3008021110-2022-00093
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

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: 1322.09.500
• Device Lot Number: 1206118
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2023
• 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