MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; SMALL-R BASEPLATE EXTRACTOR

Model Number	9013.75.391
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation a review of the device history records (dhrs) for lots 21bh07z and 23bh03a was conducted.No pre-existing anomalies were identified among the 60 and 31 devices manufactured in these respective lots.A review of the device history records (dhrs) for lot 15aq00r was also conducted.No pre-existing anomalies were identified among the 30 devices manufactured in this lot.This is the first and only complaint about these lot.A final mdr report will be shared upon completion of the investigation.
Event or Problem Description
During a shoulder prosthesis revision performed on (b)(6) 2026, an intra-operative issue related to the instrumentation was encountered.The surgeon experienced difficulties using two baseplate extractor small-r devices (product code 9013.75.391; lot 21bh07z and lot 23bh03a) to remove the baseplate from the tt peg.Specifically, the splines of the extractors bent during the extraction attempts, making it impossible to disengage the baseplate from the peg.In addition, the small-r cannulated reamer (product code 9013.75.395; lot 15aq00r), intended for tt peg removal, was difficult to use, partly due to the absence of an appropriate leverage handle.As a result of these difficulties, an alternative instrument (bristow) was used; however, despite multiple attempts, the peg could not be removed.The surgeon subsequently modified the surgical plan: the original peg was left in situ, and a new baseplate with new screws was implanted onto the existing peg.The size of the glenosphere was also reduced compared to the initial plan.The overall procedure time was prolonged by approximately 45 minutes.The event occurred in australia.

• Brand Name: SMR SHOULDER
• Common Device Name: SMALL-R BASEPLATE EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24377809
• Report Number: 3008021110-2026-00134
• Device Sequence Number: 17362154
• Product Code: KWS
• UDI-Device Identifier: 08033390094856
• UDI-Public: 08033390094856
• Combination Product (Y/N): N
• PMA/510(K) Number: K133349
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9013.75.391
• Device Catalogue Number: 9013.75.391
• 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: 02/18/2026
• Supplement Report FDA Received Date: 06/22/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown