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

Model Number 1379.59.210

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #2002577, no pre-existing anomaly was detected on all the 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 shoulder surgery on (b)(6) 2020.The first attempt at seating the tt hybrid cem.Glenoid std (product code 1379.59.210, lot# 2002577 - ster.2000048) was unsuccessful as the baseplate could not achieve full seating.The implant was removed and holes re-drilled, making central hole wider to accommodate the tight press-fit of the implant's central peg.After widening of the central hole, a second implant of the same size was implanted successfully.All the instruments were used as per surgical technique.The complaint source reported that the physician believed that the initial press-fit of the implant was too tight and prevented complete seating of the implant.Prolonged surgical time of 15 minutes.The patient is a male, (b)(6) years old, he had dense cancellous bone.

Manufacturer Narrative

Investigation by checking the manufacturing charts of the involved lot number, no pre-existing anomaly was found on a total of 17 items manufactured with the same lot number.According to our records, all the 17 hybrid glenoids with lot number 2002577 and sterilization 2000048 have been implanted and this is the only complaint received on this lot number.Explant analysis the hybrid glenoid has been received by limacorporate for further analysis.Dimensional checks were performed on the returned item and the measurements did not highlight any anomaly that could have contributed to the event.X-rays analysis limacorporate received one x-ray referring to post-operative surgery.The x-rays received - exact date not known - has been seen, however it does not provide any technical information regarding the positioning of the first trialed hybrid glenoid.Therefore, the x-ray cannot be evaluated.Considering that: - check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot number 2002577.- according to the analysis of the returned item, the dimensional check did not highlight any anomaly that could have contributed to the event.We can conclude that the event was not product related.An improvement of the smr tt hybrid glenoid drill 9013.79.500 (v.01) was introduced to reduce the risk of incorrect implant seating, especially in cases of sclerotic bone.This activity was initiated as a preventive action in 2018.The new instrument in v.02 is currently available on the market.Pms data according to our pms data, we can estimate the occurrence rate of the intra-operative difficulty in seating hybrid glenoids - belonging to product code 1379.59.Xxx - to be around 0.09%.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Intra-op event experienced during shoulder surgery on (b)(6) 2020.The first attempt in seating the tt hybrid cemented glenoid std (product code 1379.59.210, lot number 2002577, sterilization 2000048) was unsuccessful as the baseplate could not achieve full seating.The implant was removed and holes re-drilled, making central hole wider to accommodate the press-fit of the implant's central peg.After widening of the central hole, a second implant of the same size was implanted successfully.All the instruments were used as per surgical technique.The complaint source reported that the physician believed that the initial press-fit of the implant was too tight and prevented complete seating of the implant.It was reported that surgery was prolonged of 15 minutes.Patient is a male, 59 years old.It was reported that patient had dense cancellous bone.Event happened in united states.

• Brand Name: TT HYBRID CEM. GLENOID STD
• Type of Device: HYBRID GLENOID STD - PEG S
• 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: 10605029
• MDR Text Key: 214821842
• Report Number: 3008021110-2020-00075
• 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: 04/30/2024

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: 1379.59.210
• Device Catalogue Number: 1379.59.210
• Device Lot Number: 2002577
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2024
• 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