MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TRIAL STEM WITH QUICK CONNECTION; DIA. 20 - TRIAL STEM WITH QUICK CONNECTION

Model Number 9013.02.202

Device Problem Measurement System Incompatibility (2982)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lot#: 20aq27y, no pre-existing anomaly was found on the components manufactured with the same lot#.This is the first and only complaint received on this lot#.We submit a final mdr as soon as the investigation is completed.

Event Description

During a primary shoulder surgery performed on (b)(6) 2022, it was reported that the trial stem with quick connection (product code: 9013.02.202, lot#: 20aq27y) was trialled and the 20mm definitive stem was going to be implanted.The implants were double checked and opened.It was reported that when the surgeon went to implant the 20 mm smr cementless finned stem (product code: 1304.15.200, lot#: 2105731 - ster: (b)(4), the trial stem didn't match the height of the definitive stem as it was sitting too proud of the bone.According to the received information, the surgeon believed there was a discrepancy between the two.A 19mm definitive stem was opened and used.The number of uses of the trial stem is not known.It was reported that surgery got prolonged by 20 minutes due to the issue.Event happened in australia.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #20aq27y, no pre-existing anomaly is found on the components manufactured with the same lot #.This is the first and only complaint received on this lot #.In addition, manufacturing charts of lot #2105731 are checked and no pre-existing anomaly is found.According to our records, at least 27 out of 30 20 mm smr cementless finned stem with lot #2105731 - ster.2100134 have been implanted and no complaint has been received on this lot #.Device analysis the trial stem involved in the complaint was returned to limacorporate for analysis.The visual inspection found no anomalies.A dimensional analysis was performed, and the device was proven to be within the specifics.In details, the height of the trial stem was checked, and it was found to be within the tolerances.Given that the fitting of the device to the bone depends also on the item's diameter, the measure of fins diameter was taken as well, confirming its compliance to the specifics.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that: · check of the manufacturing charts highlighted no anomalies on the components manufactured with lot #20aq27y; · check of the manufacturing charts found no pre-existing anomalies on the components manufactured with lot #2105731, in addition no complaint has been received on this lot #; · the dimensional analysis performed on the involved trial stem confirmed that the components is compliant to the specifics; we can state that the event was not product related.Pms data according to our pms data, we can estimate the occurrence rate of intra-operative discrepancy in fitting between trial stems with quick connection belonging to product codes 9013.02.1x2 and 9013.02.2x2 and definitive stems of same size to be 0.021% (ww).Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments but only the total number of pieces manufactured.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.Note: this is a final mdr.

Event Description

During a primary shoulder surgery performed on (b)(6) 2022, it was reported that after trialling the trial stem with quick connection (product code 9013.02.202, lot #20aq27y), the 20mm definitive stem was going to be implanted.The implants were double checked and opened.It was reported that when the surgeon went to implant the 20 mm smr cementless finned stem (product code 1304.15.200, lot #2105731 - ster.2100134), the trial stem didn't match the height of the definitive stem as it was sitting too proud of the bone.According to the received information, the surgeon believed there was a discrepancy between the two.A 19mm definitive stem was opened and used.The number of uses of the trial stem is not known.It was reported that surgery got prolonged by 20 minutes due to the issue.Event happened in australia.

• Brand Name: TRIAL STEM WITH QUICK CONNECTION
• Type of Device: DIA. 20 - TRIAL STEM WITH QUICK CONNECTION
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 15649301
• MDR Text Key: 306938850
• Report Number: 3008021110-2022-00099
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9013.02.202
• Device Lot Number: 20AQ27Y
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other