MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø44 MM; HUMERAL HEADS (COCRMO) DIA.44MM

Model Number 1322.09.440

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Muscle/Tendon Damage (4532); Implant Pain (4561)

Event Date 09/07/2023

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2023, due to cuff failure and pain.Surgeon noted that possibly the humerus was too high.The following components got explanted and the prosthesis was converted to reverse: smr humeral head ø44 mm (product code: 1322.09.440, lot#: 1805916 - ster.1800148).Smr eccentric adaptor taper standard (product code: 1330.15.274, lot#:1809773 - ster.1800233).Smr trauma humeral body # medium (product code: 1350.15.010, lot#:1814079 - ster.1800317).Cemented glenoid 3 pegs small (product code: 1379.51.020, lot#: 17at0x9 - ster.1800086).Primary surgery took place on (b)(6) 2018.Patient is a female, 60 years old.No clinical info is available.It was reported that patient had 3-4 previous surgeries after the proximal humeral fracture, but no information is available on them.Event happened in new zealand.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot#: 1805916, no pre-existing anomalies were found on the 68 components manufactured with that lot#.This is the first and only complaint received on the lot#.We submit a final mdr as soon as the investigation is complete.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1805916, no pre-existing anomaly was found on the 68 components manufactured with that lot #.According to our records, at least 56 out of 68 humeral heads with lot #1805916 and ster.1800148 have been implanted and this is the only complaint received on this lot #.Device analysis the items involved were not available to return 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 unknown - has been evaluated by a medical consultant.Following, the medical consultant comments: "the radiograph shows a big bone resorption under the metaphyseal part of the prosthesis, which looks overstuffed (hard to tell with the amount of missing bone) and high riding (ahd is reduced indicating the rotator cuff failure).This is a fateful course of events after multiple operation post trauma.A surgeon issue is possible, but rather less important than the natural course.There is no implant-related problem here".Considering that: check of manufacturing charts highlighted no anomalies on components manufactured with lot #1805916; according to the surgeon responsible for the revision surgery, possibly the humerus was too high; according to the medical expert "the radiograph shows a big bone resorption under the metaphyseal part of the prosthesis, which looks overstuffed (hard to tell with the amount of missing bone) and high riding.This is a fateful course of events after multiple operation post trauma"; we can state that the event was not product related.Pms data according to limacorporate pms data, revision rate of humeral heads - belonging to the family codes 1322.09.Xxx - due to cuff failure is (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

Shoulder revision surgery of a smr anatomic total prosthesis performed on (b)(6) 2023, due to cuff failure and pain.Surgeon noted that possibly the humerus was too high.The following components got explanted and the prosthesis was converted to reverse: smr humeral head ø44 mm (product code 1322.09.440, lot #1805916 - ster.1800148).Smr eccentric adaptor taper standard (product code 1330.15.274, lot #1809773 - ster.1800233).Smr trauma humeral body # medium (product code 1350.15.010, lot #1814079 - ster.1800317).Cemented glenoid 3 pegs small (product code 1379.51.020, lot #17at0x9 - ster.1800086).Primary surgery took place on (b)(6) 2018.Patient is a female, 60 years old.No clinical info is available.It was reported that patient had 3-4 previous surgeries after the proximal humeral fracture, but no information is available on them.Event happened in new zealand.

• Brand Name: SMR HUMERAL HEAD Ø44 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.44MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 17779140
• MDR Text Key: 323789307
• Report Number: 3008021110-2023-00107
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.440
• Device Lot Number: 1805916
• 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): Required Intervention