MAUDE Adverse Event Report: LIMACORPORATE S.P.A TT HYBRID GLENOID METAL BACK

Model Number 1379.59.210

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 03/08/2022

Event Type  Injury  

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) hybrid glenoid manufactured with the same lot#.Available explants pictures + pre-op revision x-rays (no exact date) were received by limacorporate.Following, the medical consultant's opinion on the case, based on the info received: "the preop radiographs show a superiorly decentered humeral head as it might indicate rotator cuff failure which is one of the most common reasons for failure of tsa.The explant shows severe pe wear at the edges which underlines the problem with a decentered head.This can be due to imperfect positioning during the primary implantation, which we don't know for sure and it can be a fateful event as named before.Nevertheless in my opinion this is the reason for the failure and it is not implant related".We will send a final investigation report once the explants (available) will be received.

Event Description

Conversion from smr anatomic to smr reverse due to dislocation performed on (b)(6) 2022.Reason for dislocation is unknown but the tt hybrid glenoid metal back - product code 1379.59.210, lot 2101058, ster.2100100, was dissociated from tt peg.According to the info reported, the patient might have fallen (info not directly confirmed).Original surgery was performed on (b)(6) 2020.

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) hybrid glenoid manufactured with the same lot#.Available explants pictures + pre-op revision x-rays (no exact date) were received by limacorporate.Following, the medical consultant's opinion on the case, based on the info received: "the preop radiographs show a superiorly decentered humeral head as it might indicate rotator cuff failure which is one of the most common reasons for failure of tsa.The explant shows severe pe wear at the edges which underlines the problem with a decentered head.This can be due to imperfect positioning during the primary implantation, which we don't know for sure and it can be a fateful event as named before.Neverthless in my opinion this is the reason for the failure, and it is not implant related".In conclusion, considering that: - no anomaly was found by checking the manufacturing charts of the involved lot number.- the medical expert's evaluation this can be due to imperfect positioning during the primary implantation.In his opinion this is the reason for the failure, and it is not implant related.We can suppose that the issue was not product related.Pms data according to limacorporate pms data for tt hybrid cem.Glenoid std commercial code (b)(4) revision rate for dislocation is (b)(4).No specific corrective action is needed for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issues.Note this is the final mdr.

Event Description

Conversion from smr anatomic to smr reverse due to dislocation performed on (b)(6) 2022.Reason for dislocation is unknown but the tt hybrid glenoid metal back - product code 1379.59.210, lot 2101058, ster.(b)(4), was dissociated from tt peg.According to the info reported, the patient might have fallen (info not directly confirmed).Original surgery was performed on (b)(6) 2020.Event happened in u.S.

• Brand Name: TT HYBRID GLENOID METAL BACK
• Type of Device: TT HYBRID GLENOID METAL BACK
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale, 52; villanova di san daniele, udine 33038
• MDR Report Key: 13938894
• MDR Text Key: 289600500
• Report Number: 3008021110-2022-00020
• Device Sequence Number: 1
• Product Code: KWS
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1379.59.210
• Device Catalogue Number: 1379.59.210
• Device Lot Number: 2101058
• Is the Reporter a Health Professional?: No
• 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
• Patient Age: 63 YR
• Patient Sex: Male