MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CTA HUMERAL HEAD Ø50 MM

Model Number 1323.09.500

Device Problem Mechanical Problem (1384)

Patient Problem Joint Laxity (4526)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the humeral heads that belong to lot number 1404736 ster.2000264.This is the first and only complaint registered on this lot number.A final report will be submitted after the conclusion of the investigation.

Event Description

Shoulder revision surgery due to instability performed on (b)(6) 2022.The following devices were explanted: code 1323.09.500 lot 1404736 ster.2000264 smr cta humeral head ø50 mm; code 135015030002 lot 1909751 ster.1900275 smr trauma hum.Body # short; code 1330.15.272 lot 1916854 ster.1900405 smr ecc.Adaptor taper standard.The patient is male, born on (b)(6) 1960 and has a bmi of 28 kg/m2.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 215/22 (not reported to the fda as the involved device is not fda cleared) the second revision surgery, due to instability, was performed on (b)(6) 2022.The prosthesis was replaced with a reverse configuration.This event is the object of this report.The third revision surgery took place on (b)(6) 2022 and was registered as complaint 204/22 (fda ref: 3008021110-2022-00076).A fourth revision surgery has been planned with a custom-made device.This event occurred in (b)(6).

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the humeral heads that belong to lot number: 1404736 ster.2000264.This is the first and only complaint registered on this lot number.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 on (b)(6) 2021.The post -operative x-rays of the second revision surgery, dated on (b)(6) 2022.The pre-operative x-rays of the third revision surgery, dated on (b)(6) 2022.The pre-operative x-rays of the fourth revision surgery, dated on (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 curtibacterium acnes involved in the surgery on (b)(6) 2021.I do not see anything related to failure of the implants here." moreover, with reference to the surgery performed on (b)(6), 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 on (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? 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 on (b)(6) 2021), the presence of curtibacterium acnes could have contributed to the necessity of revision surgery, focusing on the third revision surgery (dated on (b)(6) 2022), the reported suboptimal bone contact could not be confirmed nor excluded by the x-rays analysis.During the revision surgery dated on (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 corrective action needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Shoulder revision surgery due to instability performed on (b)(6) 2022.The previous surgery took place on (b)(6) 2021.The following devices were explanted: code 1323.09.500 lot: 1404736 ster.2000264 smr cta humeral head ø50 mm.Code 1350.15.030 lot: 1909751 ster.1900275 smr trauma hum.Body # short.Code 1330.15.272 lot: 1916854 ster.1900405 smr ecc.Adaptor taper standard.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 curtibacterium 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.On (b)(6) 2022 (fda ref.3008021110-2022-00079).The third revision surgery due to glenoid implant loosening and scapula fracture 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:(b)(4)(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.

• Brand Name: SMR CTA HUMERAL HEAD Ø50 MM
• Type of Device: SMR CTA HUMERAL HEAD Ø50 MM
• Manufacturer (Section D): 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: 15310409
• MDR Text Key: 298775145
• Report Number: 3008021110-2022-00079
• 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: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1323.09.500
• Device Lot Number: 1404736
• 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