MAUDE Adverse Event Report: LIMACORPORATE SPA SMR - EXTRACTOR FOR GLENOID; SMR - EXTRACTOR FOR GLENOID (KWT, HSD)

Model Number 9013.02.310

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the involved lot numbers, no anomaly was found.We will submit a final mdr once the investigation will be concluded.

Event Description

Intra-operative issue occurred during smr revision surgery performed on (b)(6) 2019.While the surgeon was removing previous components, the tip of smr - extractor for glenoid code 9013.02.310 lot #15aa138b broke off inside glenoid removal device and the tip of smr - stem extractor code 9013.02.301 broke off inside stem.The lot #s 15aa270a and 14aa492a of two different smr-stem extractors were provided, but it is still unknown which one broke off during surgery.According to the info reported, the stem was very difficult to be removed due to bone ingrowth.The instruments were used approximately 150 times.This event prolonged the surgery of 20 minutes.

• Brand Name: SMR - EXTRACTOR FOR GLENOID
• Type of Device: SMR - EXTRACTOR FOR GLENOID (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8859019
• MDR Text Key: 200394410
• Report Number: 3008021110-2019-00087
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.02.310
• Device Lot Number: 15AA138B
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization