MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CTA HUMERAL HEAD Ø54 MM; CTA HUMERAL HEADS (COCRMO) DIA.54MM

Model Number 1323.09.540

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/08/2023

Event Type  Injury  

Event Description

Revision surgery performed on (b)(6) 2023, as second stage surgery to implant a customized glenoid baseplate (cmd 22-1190).The following components were explanted.Smr cta humeral head ø54 mm (product code 1323.09.540, lot #1208695 - ster.1800062).Smr cta heads adaptor ø36 mm (product code 1352.15.200, lot #1906120 - ster.1900165).Smr reverse humeral body (product code 1352.20.010, lot #1605361 - ster.1600145) - product not sold in the us.The prosthesis got converted to smr reverse.Patient is a male, 76 years old.It was reported he is active and has an average bmi.His history of shoulder history is the following: primary surgery on june 20th, 2016 to place in a smr reverse implant; first stage revision surgery performed on (b)(6) 2020, for failed reverse (reason for failure is unknown).The smr reverse prosthesis got converted to a hemi implant; second stage revision surgery performed on (b)(6) 2023, to convert to smr reverse using a customized glenoid component (hereby reported).Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1208695, no pre-existing anomalies were found on the 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 #1208695, no pre-existing anomalies were found on the components manufactured with that lot #.Device 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 - dated (b)(6) 2022 - has been evaluated by a medical consultant.The medical consultant commented: "as far as i can see, this is just a fateful course of events.There is no obvious implant related issue here".Based on the available information, no further analysis on the root cause of the event is feasible.Considering that: · check of the manufacturing charts highlighted no anomalies on the components manufactured with lot #1208695; · according to the received information, this is a second-stage revision surgery needed to implant the customized glenoid.The reason for the failure of the original smr reverse implant is unknown; · according to the medical expert, the latter revision surgery shows no signs of implant-related issues; we can state that the event was not product related.Pms data according to limacorporate pms data, the revision rate of smr anatomic hemi prostheses use as temporary joint replacements (thus in two-stages surgeries) 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 continues monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Revision surgery performed on (b)(6) 2023, as second stage surgery to implant a customized glenoid baseplate (cmd 22-1190).The following components were explanted.· smr cta humeral head ø54 mm (product code 1323.09.540, lot #1208695 - ster.1800062) · smr cta heads adaptor ø36 mm (product code 1352.15.200, lot #1906120 - ster.1900165) · smr reverse humeral body (product code 1352.20.010, lot #1605361 - ster.1600145) - product not sold in the us.The prosthesis got converted to smr reverse using the customized glenoid baseplate.Patient is a male, 76 years old.It was reported he is active and has an average bmi.His history of shoulder history is the following: · primary surgery on (b)(6) 2016, to place in a smr reverse implant; · first stage revision surgery performed on (b)(6) 2020, for failed reverse (reason for failure is unknown).The smr reverse prosthesis got converted to a hemi implant; · second stage revision surgery performed on (b)(6) 2023, to convert to smr reverse using a customized glenoid component (hereby reported).A broken screw's part was left behind on the glenoid during the first revision as it could not be removed easily.The broken screw was left there on the second revision surgery as well, because the surgeon was not going to dig it out and potentially create a defect worse than before.The customized glenoid was designed so that it could be implanted, and the broken screw would not impact the fixation.From the surgeon's perspective, the custom implants fixation was very solid.Event happened in australia.

• Brand Name: SMR CTA HUMERAL HEAD Ø54 MM
• Type of Device: CTA HUMERAL HEADS (COCRMO) DIA.54MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 16944808
• MDR Text Key: 315357755
• Report Number: 3008021110-2023-00057
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110847
• 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: 09/04/2023

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: 1323.09.540
• Device Lot Number: 1208695
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2023
• 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): Other