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 Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

Checking the dhr of the involved lot #s, no pre-existing anomaly was found on the components that were released on the market with the same lot #s (#1300536, #1415223 and #1904808).This is the first and only complaint received on these lot #s.We will submit a final mdr as soon as the investigation will be completed.

Event Description

Shoulder revision surgery of a smr stemless anatomic implant performed on (b)(6) 2021, due to pain and mal-positioned components.It was reported that the glenoid was changed and the head repositioned downwards and thickness reduced.The following components were removed: smr humeral head ø50 mm (product code 1322.09.500, lot # 1300536 - ster.1900334), smr stemless - 4mm eccentric adaptor (product code 1335.15.204, lot #1415223 - ster.1500179), tt hybrid cemented glenoid small (product code 1379.59.110, lot #1904808 - ster.1900124).Previous surgery took place on (b)(6) 2019.Patient is a male, (b)(6).Event happened in (b)(6).

Manufacturer Narrative

By checking the manufacturing charts of the involved lot #1300536, no pre-existing anomaly was found on the item manufactured with lot #1300536 - ster.1900334.By checking the manufacturing charts of the involved lot #1415223 - ster.1500179, no pre-existing anomaly was found on a total of 32 items manufactured with the same lot # - ster.According to our records, at least 17 out of 32 smr stemless adaptors with lot #1415223 - ster.1500179 have been implanted and this is the only complaint received on this lot #.By checking the manufacturing charts of the involved lot #1904808, no pre-existing anomaly was found on a total of 16 items manufactured with the same lot #.According to our records, at least 15 out of 16 hybrid glenoids with lot #1904808 - ster.1900124 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 provided radiograph shows a malpositioned humeral head and gross overstuffing of the joint.This very much looks like a surgical error.Regarding the device, i think this is not related, regarding the surgical procedure, relation is probable".Considering that: · check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lots #1300536, #1415223 and #1904808; · according to the medical consultant "the provided radiograph shows a malpositioned humeral head and gross overstuffing of the joint"; we can state that the event was surgical-factor related.Pms data according to limacorporate pms data, revision rate of smr stemless anatomic prosthesis due to pain is 0.03%.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 of a smr stemless anatomic implant performed on (b)(6), 2021, due to pain and mal-positioned components.It was reported that the glenoid was changed and the head repositioned downwards and thickness reduced.The following components were removed: smr humeral head ø50 mm (product code 1322.09.500, lot #1300536 - ster.1900334) smr stemless - 4mm eccentric adaptor (product code 1335.15.204, lot #1415223 - ster.1500179) tt hybrid cemented glenoid small (product code 1379.59.110, lot #1904808 - ster.1900124) previous surgery took place on (b)(6) 2019.Patient is a male, approximately 45 years old.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: 13010699
• MDR Text Key: 282789732
• Report Number: 3008021110-2021-00103
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.500
• Device Lot Number: 1300536
• Is the Reporter a Health Professional?: No
• 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