MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TT HYBRID CEM. GLENOID #S LOW; HYBRID GLENOID SMALL LOW - PEG S

Model Number 1379.59.100

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #1906362, no pre-existing anomaly was detected on the 18 components manufactured with this lot #.This is the first and only complaint received on this lot number.We will submit a final mdr once the investigation will be completed.

Event Description

Intra-op event experienced during a shoulder surgery (conversion from anatomic implant to reverse) performed on (b)(6) 2020.The surgeon attempted to remove the poly part of the tt hybrid cem.Glenoid #s low (product code 1379.59.100, lot# 1906362 - ster.1900156) from the peg but it would not disengage.It was reported that the surgeon was unable to remove the poly part despite following the surgical technique.In order to succeed with the conversion, the surgeon had to break the polyethylene, retaining the hybrid peg in situ and operating the conversion.The revision surgery was registered as complaint # (b)(4) and reported to the fda as mfr 3008021110-2020-00079.Surgery was prolonged of about one hour.The product was implanted on the previous surgery of (b)(6) 2019.Patient is a male, (b)(6).Event happened in (b)(6).

• Brand Name: TT HYBRID CEM. GLENOID #S LOW
• Type of Device: HYBRID GLENOID SMALL LOW - PEG S
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10618479
• MDR Text Key: 239727782
• Report Number: 3008021110-2020-00078
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K163397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1379.59.100
• Device Catalogue Number: 1379.59.100
• Device Lot Number: 1906362
• 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): Other