MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CONNECTOR SMALL R; CONNECTOR WITH SCREW SMALL-R

Model Number 1374.15.305

Device Problems Break (1069); Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 04/13/2019

Event Type  Injury  

Event Description

5th revision surgery of a smr reverse prosthesis performed on (b)(6) 2019 due to pain.X-rays conducted on (b)(6) showed metal back glenoid loosening and migration superiorly.A screw breakage was also reported by the complaint source but is unknown if any patient traumatic event could have contributed to this item breakage.The patient has a history of falling and physical excursion.Patient has also a history of shoulder problems and surgeries: a total of 7 complaints related to this patient (including this one) have been reported to limacorporate on (b)(6) 2022: initial surgery (reverse prosthesis) on (b)(6) 2017; first revision surgery on (b)(6) 2018 (lima complaint # (b)(4),- 3008021110-2022-00032); second revision surgery on (b)(6) 2018 (lima complaint # (b)(4),3008021110-2022-00033); third revision surgery on (b)(6) 2019 (lima complaint # (b)(4), not reportable to fda); fourth revision surgery on (b)(6) 2019 (lima complaint # (b)(4),3008021110-2022-00034); fifth revision surgery on (b)(6) 2019 (object of this report, 3008021110-2022-00035); sixth revision surgery on (b)(6) 2019 (lima complaint # (b)(4), not reportable to fda); dislocation to be solved with a compassionate use device (lima complaint #(b)(4), not reportable to fda) event happened in us.

Manufacturer Narrative

Manufacturing records were checked confirming the batch number involved was manufactured correctly up to specification and in-line with the relevant checks and tests.No manufacturing deviations were reported.No other complaints received on a total of (b)(4) smr connector small r manufactured with the same lot (1813659).Besides the event description, no additional info to be possibly recoverable for this case.Based on the check of the manufacturing charts, we can rely this case is not product related.According to limacorporate pms data, revision rate of smr reverse prosthesis due to pain is (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.

• Brand Name: SMR CONNECTOR SMALL R
• Type of Device: CONNECTOR WITH SCREW SMALL-R
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 14367117
• MDR Text Key: 294763657
• Report Number: 3008021110-2022-00035
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

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: 1374.15.305
• Device Lot Number: 1813659
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2022
• 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