MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR GLENOID PEG TT SMALL-R #M; SMR TT METAL BACK PEG (TI6AL4V) - S-R MEDIUM

Model Number 1375.14.652

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/02/2022

Event Type  Injury  

Event Description

Intra-operative bone fracture occurred on (b)(6) 2022, during smr reverse surgery.According the information received, the cause of the fracture was attributed to the size of the peg (product code 1375.14.652, lot 2202842, ster.2200084), too large for the patient, which was described as small, with deficient glenoid.Due to the intra-operative bone fracture, hemi prosthesis was implanted with a reverse adapter and it was reported that the patient will need to be revised in the future.Patient data: female, born on (b)(6) 1938.This event occurred in the united states.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the tt pegs that were released with lot number 2202842, ster.2200084.This is the first and only complaint received on this lot number.We will submit a final mdr as soon as the investigation will be completed.

Event Description

Intra-operative bone fracture occurred on (b)(6) 2022, during smr reverse surgery.According the information received, the cause of the fracture was attributed to the size of the peg (product code 1375.14.652 lot 2202842 ster.2200084), too large for the patient, which was described as small, with deficient glenoid.Due to the intra-operative bone fracture, hemi prosthesis was implanted with a reverse adapter and it was reported that the patient will need to be revised in the future.Patient data: female, born on (b)(6).This event occurred in the united states.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the tt pegs that were released with lot number lot 2202842 ster.2200084.Product was manufactured correctly up to specification and in-line with the relevant checks and tests.No manufacturing deviations were reported.No complaints received on a total of 63 glenoid tt pegs manufactured with the same lot#.No additional details were available on this post-operative issue, preoperative or post-operative x-rays were requested but not available.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering the facts: · checking the manufacturing charts of the involved lot #, no pre-existing anomalies were found.We can suppose that the event was not product related.Pms according to limacorporate pms data, revision rate of smr glenoid peg tt small-r #m, commercial code 1375.14.Xxx for bone fracture is 0.031%.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 issues.Note: this is a final mdr.

• Brand Name: SMR GLENOID PEG TT SMALL-R #M
• Type of Device: SMR TT METAL BACK PEG (TI6AL4V) - S-R MEDIUM
• 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: 15189870
• MDR Text Key: 297500927
• Report Number: 3008021110-2022-00067
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K133349
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1375.14.652
• Device Lot Number: 2202842
• 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): Hospitalization; Disability
• Patient Age: 83 YR
• Patient Sex: Male