MAUDE Adverse Event Report: LIMACORPORATE SPA FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.21MM

Model Number 1304.15.210

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

By the check of the dhrs, no pre-existing anomaly was detected on the stems with lot# 1005438, ster.1700216.This is the first and only complaint received on the same lot#.We will submit the final report as soon as the investigation will be completed.

Event Description

Intra-operative issue experienced during shoulder surgery on (b)(64) 2021: the smr stem with code 1304.15.210 and lot#1005438, ster.1700216 was opened, but the internal packaging was damaged.A stem with a different size (stem with code 1304.15.220) was therefore used to complete the surgery.No consequences for the patient nor prolonged surgery time were reported due to this issue.Event occurred in (b)(6).

Event Description

Intra-operative issue experienced during shoulder surgery on (b)(6) 2021: the smr stem with code 1304.15.210 and lot n.1005438, ster.1700216 was opened, but the internal packaging was damaged.A stem with a different size (stem with code 1304.15.220) was therefore used to complete the surgery.No consequences for the patient nor prolonged surgery time were reported due to this issue.Event occurred in germany.

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the stems with lot n.1005438, ster.1700216, thus we can state that the component was released on the market compliant to specifications.This is the first and only complaint received on the same lot number (1005438, ster.1700216).We received some photos of the broken package, where it appears torn, both the pouches (inner and external) are damaged.We believe that this kind of damage could be related to an incorrect handling during transport and/or as a consequence of a fall or impact: it is very unlikely that these damages may have occurred during standard transport/storage.In conclusion, stating that: - by the check of the production documents, no pre-existing anomalies were identified on the lot number involved; - limacorporate is not aware of any other complaint on the same production or sterilization lot numbers; - the damage visible on the available photos suggests it may have been caused by an incorrect handling.It is not possible to determine with certainty the cause of the breakage of the package, but it seems to be related to external factors such as incorrect handling of the item.In addition, it should be noted that the indications provided by the manufacturer, reported on the packaging and on the instruction for use, clearly specify that the device must not be used if the package is damaged.Pms data: based on limacorporate pms data, the occurence rate of this kind of intra-operative issues with smr cementless finned stems (product codes 1304.15.Xxx) is (b)(4)%.The stem involved in this specific complaint is packaged with the most recent packaging version, meaning that it has an internal pa pouch + 2 vacuumed pouches + an external box with protective sponges.The last version of the packaging was introduced in 2016.Considering only the smr stems with codes 1304.15.Xxx packaged with the most recent version of the packaging, we can estimate an occurrence rate of this kind of intra-operative issue of (b)(4)%.No corrective action is needed for this specific complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.21MM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.21MM
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12032549
• MDR Text Key: 280777310
• Report Number: 3008021110-2021-00047
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1304.15.210
• Device Lot Number: 1005438 STER. 1700216
• 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