MAUDE Adverse Event Report: LIMACORPORATE SPA SMR TT AUGMENTED 360 BASEPLATE S-R 15°

Model Number 1375.15.515

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/23/2022

Event Type  Injury  

Event Description

Shoulder revision surgery due to bone fracture performed on (b)(6) 2022.The prosthesis was converted to hemi prosthesis with cta humeral head.The complaint source reported the metal back (product code 1375.15.515, lot n.2023578) was not 100% in contact with the bone and it was used with a +44mm lateralized connector (product code 1374.15.314, lot n.2009174) which is an off-label combination.In addition to the baseplate and connector, the following devices were explanted: peg 1375.14.653 lot 1815651; hp glenosphere 1374.50.440 lot 2114870 ; reverse liner 1362.09.015 lot 2119267.The patient is male, born on (b)(6) 1960 and has a bmi of 28 kg/m2.According to the information received, this revision surgery was the third one for this patient and a further revision with a custom-made device has now been planned.The 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 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 is the object of this incident report and took place on (b)(6) 2022 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 10 baseplates that belong to lot number 2023578.This is the first and only complaint registered on this lot number.A final report will be submitted after the conclusion of the investigation.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the 10 metal back glenoids that belong to lot number 2023578.According to our records, all the metal back glenoid with lot 2023578, have already been implanted and 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 (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 10.12.21 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, the revision rate due to bone fracture and/or loosening of the augmented 360 glenoid (family code 1375.15.5xx) is about (b)(4).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 pain, bone fracture and loosening of the metal back glenoid performed on (b)(6) 2022.The prosthesis was converted to hemi prosthesis with cta humeral head and bone augmentation with bone chip from iliac crest.The complaint source reported the metal back (product code 1375.15.515, lot n.2023578) was not 100% in contact with the bone and it was used with a +4 mm lateralized connector (product code 1374.15.314, lot n.2009174) which is an off-label combination.In addition to the baseplate and connector, the following devices were explanted: smr glenoid peg tt small-r #l 1375.14.653 lot 1815651, smr reverse hp glenosph.44 mm 1374.50.440 lot 2114870, smr reverse hp liner medium 1362.09.015 lot 2119267, 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.(b)(6) (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.(b)(4) (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.

• Brand Name: SMR TT AUGMENTED 360 BASEPLATE S-R 15°
• Type of Device: SMR TT AUGMENTED 360 BASEPLATE S-R 15°
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15310359
• MDR Text Key: 298773727
• Report Number: 3008021110-2022-00076
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K191746
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1375.15.515
• Device Catalogue Number: 1375.15.515
• Device Lot Number: 2023578
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2023
• 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): Required Intervention