MAUDE Adverse Event Report: LIMACORPORATE S.P.A. FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.23MM

Model Number 1304.15.230

Device Problem Break (1069)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

By the check of the production documents, no pre-existing anomaly was found on the components belonging to the two lot#s involved (lot 1709172 ster 1700246, lot 1904971 ster 1900226).We will submit a final mdr as soon as the investigation will be completed.

Event Description

Intra-operative issue occurred on the (b)(6) 2021: during the surgery, the packaging of two smr stems were found damaged.The product information of the components involved are the following: smr cementless finned stem code 130415230 lot 1709172 ster 1700246.Smr cementless finned stem code 130415240 lot 1904971 ster 1900226.According to the information received, the internal pouches of both the stems were torn, the external pouch of the 24 mm stem (code 1304.15.240) was damaged, while the external pouch of the 23mm stem (code 1304.15.240) was intact.This issue caused 5 minutes of delay to complete the surgery.The original plan was to implant the 24 mm stem, but eventually the 23mm stem was implanted.Event occurred in (b)(6).

Manufacturer Narrative

Investigation: checking the manufacturing charts of the involved lot number 1709172, no pre-existing anomaly was found on 34 smr cementless finned stems belonging to the same lot number.Checking the manufacturing charts of the involved lot number 1904971, no pre-existing anomaly was found on the 34 smr cementless finned stems belonging to the same lot number.Components analysis: it was only possible to perform an analysis through the observation of the pictures of the packages involved, because the components were no longer available to be returned.The packaging involved in this complaint has an internal pa pouch, 2 vacuumed pouches and box with protective sponges.This kind of packaging was introduced in 2016.By observing the images, 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: - no pre-existing anomaly was found on the lot numbers involved - 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 items.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: according to the limacorporate pms data, the estimated occurrence rate of this kind of intra-operative issues with smr cementless finned stems (product code 1304.15.Xxx) is about 0.01%.No corrective action is needed for this specific complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.This is a final mdr.

Event Description

Intra-operative issue occurred on the august 18th ,2021: during the surgery, the packaging of two smr stems were found damaged.The product information of the components involved are the following: · smr cementless finned stem , product code 1304.15.230, lot number 1709172, sterilization number 1700246.· smr cementless finned stem , product code 1304.15.240, lot number 1904971, sterilization number 1900226.According to the information received, the internal pouches of both the stems were torn, the external pouch of the 24 mm stem (code 1304.15.240) was damaged, while the external pouch of the 23mm stem (code 1304.15.240) was intact.This issue caused 5 minutes of delay to complete the surgery.The original plan was to implant the 24 mm stem, but eventually the 23mm stem was implanted.Event occurred in italy.

• Brand Name: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.23MM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.23MM
• 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: 12437506
• MDR Text Key: 271657137
• Report Number: 3008021110-2021-00073
• 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
• Report Date: 03/23/2023

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: 1304.15.230
• Device Lot Number: 1709172
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2023
• 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): Hospitalization