MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR METAL BACK; METAL-BACK (TI6AL4V + POROTI) SMALL-R

Model Number	UNCEMENTED GLENOID
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
From the check of the dhr, no anomaly emerged on the devices involved, thus indicating that the pieces were manufactured in compliance with specifications.In particular, no other complaints received on the same lot# (201511383) on a total of (b)(4) smr metal back glenoid manufactured with the same lot#.Post-op x-rays related to the surgery done on (b)(6) 2016 were asked in order to understand the potential relationship between the prosthesis and scapular spine fracture.No explants involved since no revision surgery was planned/done.We will send a final mdr once the investigation will be completed.
Event or Problem Description
Reverse shoulder arthroplasty on the right arm on a patient with rotator cuff tear was performed on (b)(6) 2016.At the 6 month-follow-up, on (b)(6) 2016, scapular spine fracture was observed.According to the info reported, surgeon judged this scapular spine fracture as non serious.Neither revision surgery performed nor planned (wait-and-see approach adopted by suspending the previous rehabilitation).Event happened on (b)(6).
Additional Manufacturer Narrative
From the check of the dhr, no anomaly emerged on the devices involved, thus indicating that the pieces were manufactured in compliance with specifications.In particular, no other complaints received on the same lot# (201511383) on a total of 57 smr metal back glenoid manufactured with the same lot#.Post-op x-rays related to the surgery done on (b)(6) 2016 were asked in order to understand the potential relationship between the prosthesis and scapular spine fracture.No explants involved since no revision surgery was planned/done.The physician of the hospital that was in charge of following the patient has reported the following regarding the event: the severity is considered to be non-serious.The casual relationship between the event and the medical device is unknown.X-rays imagine evaluation do not show a dislocation or loosening of the implant.In conclusion, considering the analysis of the few available information we are not able to determine with certainty the root cause of the event.We may classify this complaint as not product related.Pms data: according to limacorporte pms data, post-operative events due bone fracture when smr metal back glenoid (product code: 1375.21.Xxx) was implanted is nearly 0.01%.No corrective actions needed following this complaint, limacorporate will continue monitoring the market to promptly detect any further similar event.This is a final mdr report.Note: the complaint was closed in 2017, however final mdr was not submitted due to internal error.Complaint is therefore formally closed today according to the analysis performed at the time of closure.
Event or Problem Description
At the 6 month-follow-up, on (b)(6) 2016, scapular spine fracture was observed.According to the info reported, surgeon judged this scapular spine fracture as non serious.Neither revision surgery performed nor planned (wait-and-see approach adopted by suspending the previous rehabilitation).Event happened on japan.

• Brand Name: SMR METAL BACK
• Common Device Name: METAL-BACK (TI6AL4V + POROTI) SMALL-R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; italy ; IT
• MDR Report Key: 6886068
• Report Number: 3008021110-2017-00085
• Device Sequence Number: 18956691
• Product Code: KWS
• UDI-Device Identifier: 08033390080446
• UDI-Public: 08033390080446
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: UNCEMENTED GLENOID
• Device Catalogue Number: 1375.21.005
• Device Lot Number: 1511383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 01/07/2025
• 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
• Patient Sex: Unknown