MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SYSTEM; SMR GLENOID PEG TT SMALL-R #L

Model Number	1375.14.653
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
By the check of the device history records of the metal back glenoid involved (code 1375.15.650, lot 1514020), no pre-existing anomaly was detected on the devices released with the same lot number.By the check of the device history records of the peg used in combination with the metal back involved (code 1375.14.653, lot 1515025), no pre-existing anomaly was detected on the devices released with the same lot number.This is the first and only complaint on these lot numbers.We will submit a final report after the final investigation.
Event or Problem Description
Shoulder revision surgery due to loosening of the baseplate smr glenoid baseplate small-r, code 137515650, lot 1514020.(this product code is not cleared in the usa, but it was used in combination with the peg with code 1375.14.653, lot 1515025).The revision surgery date is (b)(6) 2018, the original surgery took place in two stages (b)(6) 2016 and (b)(6) 2016).According to the complaint source, the baseplate had detached from the bone together with the screw and the glenosphere.Patient data: male, born in 1957, height 162 cm, weight 52kg, smoking.This event occurred in the uk.
Additional Manufacturer Narrative
By the check of the device history records of the metal back glenoid involved (code 1375.15.650, lot 1514020), no pre-existing anomaly was detected on the devices released with the same lot number.By the check of the device history records of the peg used in combination with the metal back involved (code 1375.14.653, lot 1515025), no pre-existing anomaly was detected on the devices released with the same lot number.According to the pms data at least (b)(4) smr glenoid peg tt small-r #l (code 1375.14.653) manufactured with lot 1515025 have been implanted and this is the first and only complaint received on this lot number.According to the pms data at least (b)(4) pieces smr glenoid baseplate small-r (code 1375.15.650) manufactured with lot 1514020 have been implanted and this is the first and only complaint received on this lot number.The explanted devices were not returned to limacorporate for further investigation.Limacorporate received pre- and post-operative x-rays of revision surgery.The available information and x-rays have been evaluated by a medical consultant.Following, the medical consultant comments: "the patient had at least 3 operations: index, revision with removal of humeral parts (radiograph) and revision with explantation of gleonid component and implantion of humeral component (radiograph).Without knowing something about the index operation and the need for the first revision, i think this is a fateful course of events.I cannot see implant-related problems here.Based on limited information." based on the available information, we cannot determine with certainty the root cause of the event.Considering that: · the check of the device history records revealed no pre-existing anomalies in the involved lot numbers.· the explanted devices were not returned to limacorporate for further investigation.· according to the medical consultant, the x-rays and the available information indicate a fateful course of events.Additionally, no implant-related issues were identified.We conclude that the event is not product related.Pms data according to limacorporate pms data the revision rate of smr reverse due to loosening is nearly (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.This is the final mdr report.
Event or Problem Description
Shoulder revision surgery due to loosening of the baseplate smr glenoid baseplate small-r, code 137515650, lot 1514020.(this product code is not cleared in the usa, but it was used in combination with the peg with code 1375.14.653, lot 1515025).The revision surgery date is (b)(6) 2018, the original surgery took place in two stages ((b)(6) 2016 and (b)(6) 2016).According to the complaint source, the baseplate had detached from the bone together with the screw and the glenosphere.Patient data: male, born in 1957, height 162 cm, weight 52kg, smoking.This event occurred in the uk.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR GLENOID PEG TT SMALL-R #L
• Manufacturer (Section D): LIMACORPORATE S.P.A; 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: 16761155
• Report Number: 3008021110-2023-00044
• Device Sequence Number: 3061890
• Product Code: KWS
• UDI-Device Identifier: 08033390270557
• UDI-Public: 08033390270557
• Combination Product (Y/N): N
• PMA/510(K) Number: K133349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 1375.14.653
• Device Catalogue Number: 1375.14.653
• Device Lot Number: 1515025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 03/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown