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

Model Number 1323.09.540

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

Patient Problem Implant Pain (4561)

Event Date 11/04/2022

Event Type  Injury  

Event Description

Shoulder revision surgery due to pain occurred on 4th november 2022.According to the information received, the patient was not satisfied with mobility.The following devices were explanted: smr cta humeral head ø54 mm code 132309540, lot 1702748, ster.Not known, smr cta heads adaptor ø36 mm code 135215200, lot 2200887 ster.2200044, a custom-made device was then implanted.According to the information received, patient's surgical history can be summarized as follows: primary surgery (reverse shoulder arthroplasty) on (b)(6) 2021, the first revision surgery, due to loosening of the metal back glenoid, was performed on (b)(6) 2021.A cta humeral head was implanted.This event is registered as complaint (b)(4) (not reported to fda as the involved product are not marketed in usa), the second revision surgery, due instability, was performed on (b)(6) 2022.The prosthesis was replaced with a reverse configuration.This event is registered as complaint (b)(4) (fda ref.(b)(4), the third revision surgery took place on 23rd march 2022 and is registered as complaint (b)(4) (fda ref.(b)(4), fourth revision surgery (object of this incident report) with a custom-made device, performed on (b)(6) 2022.These events occurred in (b)(6).

Manufacturer Narrative

By the check of the device history records of the lot numbers involved (1702748, 2200887), no pre-existing anomaly was detected on the devices placed on the market with these lot numbers.This is the first and only complaint received on these lot numbers.We will submit a final report after the conclusion of the investigation.

Event Description

Shoulder revision surgery due to pain and instability occurred on 4th november 2022.According to the information received, the patient was not satisfied with mobility.The following devices were explanted: - smr cta humeral head ø54 mm code 1323.09.540, lot 1702748, ster.Not known - smr cta heads adaptor ø36 mm code 1352.15.200, lot 2200887 ster.2200044 a custom-made device was then implanted.According to the information received, during the revision surgery heavy scarring and metallosis were noticed.It was also reported that the over time, the screws (not manufactured by limacorporate) came out the bone/bone graft leading to a contact between cta head and screws.According to the information received, patient's surgical history can be summarized as follows: primary surgery (reverse shoulder arthroplasty) on (b)(6) 2021, a closed reduction of dislocation was performed on (b)(6) 2021, the first revision surgery, due to loosening of the metal back glenoid, was performed on (b)(6) 2021.A cta humeral head was implanted.According to the available information, microbiological test showed cutibacterium acnes.This event was registered as complaint n.215/22 (not reported to the fda as the involved device is not fda cleared) the second revision surgery, due instability, was performed on (b)(6) 2022.The prosthesis was replaced with a reverse configuration.This event was registered as complaint n.216/22 (fda ref.3008021110-2022-00079).The third revision surgery due to glenoid implant loosening took place on (b)(6) 2022 and was registered as complaint (b)(4) (fda ref.3008021110-2022-00076).The fourth revision surgery took place on (b)(6) 2022.The cause was pain and patient not satisfied with the mobility.A custom-made device was implanted.This complaint was registered under ref.Number 312/22 (fda ref.3008021110-2022-00121) the patient is male, born on (b)(6) 1960 and has a bmi of 28 kg/m2.This event occurred in germany.

Manufacturer Narrative

By the check of the device history records of the lot numbers involved (1702748, 2200887), no pre-existing anomaly was detected on the devices placed on the market with these lot numbers.This is the first and only complaint received on these lot numbers.The explanted components were not available to be returned for analysis.We received the following x-rays referring to this patient: - the post-operative x-rays of the primary rsa, dated (b)(6) 2021 - the post -operative x-rays of the second revision surgery, dated (b)(6) 2022 - the pre-operative x-rays of the third revision surgery, dated (b)(6) 2022 - the pre-operative x-rays of the fourth revision surgery, dated (b)(6) 2022 the x-rays and available operative notes, have been analyzed by a medical consultant, he commented the following: "all the surgeries make sense and the events are comprehensible.It seems to be a line of fateful events.Noteworthy, there was cutibacterium acnes involved in the surgery (b)(6) 2021 i do not see anything related to failure of the implants here" moreover, with reference to the surgery performed in december, he suggested that the presence of cut.Acnes could have contributed to the need for revision in the case.Concerning the possible suboptimal bone contact reported by the complaint source with reference to the third revision surgery (dated (b)(6) 2022), the medical consultant commented: "how can they be sure ,that the bone contact was not 100%? this would require a direct visible overlap of the metalback over the bony edges or a visible gap behind the metalback, but how could you look behind? if you have removed the metalback: how can you be sure about the amount of contact, that your just retrieved component had had? if there was a lack of bone contact, this could be a surgical error, but not necessarily.What, if it wasn't possible to do any better in the operation before, which was a revision too?" conclusion: based on the investigation performed, we cannot determine with certainty the root cause of the reported revision surgeries.The involved patient has a history of multiple revision surgeries, which, according to our medical consultant, appears to be a line of fateful events not associated to any product-related failure.The production documents check confirmed the absence of pre-existing anomaly on the involved components, therefore we can state that they were manufactured up to drawing specification and in line with relevant check and tests.On the basis of the available information, the following considerations can be made: - focusing on the first revision surgery (dated (b)(6) 2021), the presence of cutibacterium acnes could have contributed to the necessity of revision surgery, - focusing on the third revision surgery (dated (b)(6) 2022), the reported suboptimal bone contact could not be confirmed nor excluded by the x-rays analysis.- during the revision surgery dated (b)(6) 2022, an off-label components combination was implanted (augmented 360 baseplates -1375.15.Xxx- cannot be used with the lateralized connectors, moreover 44mm glenosphere - 1374.50.440- cannot be used with the lateralized connectors +4mm).The off-label combination could have possibly contributed to the further revision surgery reported.Pms data: based on limacorporate pms data, we estimate a revision rate due to instability of the cta heads of about 0.03%.No correcitve action needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: CTA HUMERAL HEADS (COCRMO) DIA.54MM
• Type of Device: CTA HUMERAL HEADS (COCRMO) DIA.54MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15860797
• MDR Text Key: 304286041
• Report Number: 3008021110-2022-00121
• Device Sequence Number: 1
• Product Code: HSD
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1323.09.540
• Device Lot Number: 1702748
• 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