MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CEMENTLESS FINNED STEM; SMR CEMENTLESS FINNED STEM (HSD-KWT)

Model Number 1304.15.190

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the lots #1815338 and #1815351, no anomaly was found on the all products manufactured with these lots.This is the first only complaint received on these lot#s.We will submit a final mdr once the investigation will be concluded.

Event Description

During surgery performed on the 3rd of september 2019, the finned stem code (b)(4), lot #1815338 was found in the package of the (b)(4), lot #1815351.The surgeon was forced to use different size (size 20 instead 19, code: (b)(4)), because in hospital there was only one smr series.This issue prolonged surgery of 20 minutes.Event happened in (b)(6).

Manufacturer Narrative

The check of the dhrs of both the lot#s involved (stem with size #22 and lot 1815338, stem with size#19 and lot 1815351) did not highlight any anomaly on the overall products manufactured with these lots.The 2 batches are composed by 35 stems each and belong to the same sterilization lot# 1800356.This is the first and only similar complaint received on these lot#s.The first hypothesis that we considered was an inversion between the two stems (#22 and #19), thus all the available #22 stems with the same lot (1815338) were checked (stems available in lima corporate or lima subsidiaries warehouses), in order to find the potential #19 stem packaged as #22.All the stems we could check were correctly packaged and labelled as size 19.In addition, among the overall number of stems # 19 (lot 1815351) that we could check, none was packaged as a #22.We therefore concluded that a stems inversion was not the most probable cause of this event.The investigation proceeded by analyzing the stems movements registered in our informatic systems: the analysis of our records showed that an inventory adjustment (-1) was performed for one stem # 22 (lot 1815338 ster.1800356).No corresponding inventory adjustment was instead made for the stem # 19.Taking into account the results of the above described analyses, of the total number of stems manufactured, moved and implanted, we reached the following conclusions that can explain the most probable cause of this issue: - one external box containing a stem #22 was unintentionally damaged during the internal handling in our supplier warehouse.The supplier operator proceeded with the immediate secondary repackaging and re-labeling of the item.A #19 label was mistakenly printed instead of the correct #22 label.The error was caused by the simultaneous presence of the two batches of stems (size #22, lot 1815338 and size#19, lot 1815351) in the department, as the two batches were processed in sequence.- upon receipt of the pieces in lima corporate warehouse, the error was not noted and the operator loaded 35 # 19 stems (as per batch work order) without noticing that the stems labeled as # 19 were instead 36 and vice versa, the stems labeled as # 22 were 34 instead of 35.The fact that the stems packaged as #22 were 34 instead of 35 is confirmed by the inventory adjustment for lot 1815338 - size 22: over time, during warehouse checks, one stem was removed from the inventory as it was missing.In conclusion, the most likely explanation for this event is not the inversion, as initially considered, but an error in the repackaging of one stem that led to one additional package of #19 stem lot #1815351 (but containing a #22 lot # 1815338 stem) and one less #22 stem (lot#1815338), while the original amount was 35 items each.The error was then not noted by the warehouse operator.Single item issue due to human error.Pms data: according to our pms data, specific occurrence rate (wrong stem found inside the package during surgery) for smr cementless stems (codes 1304.15.Xxx) is very low: 0,002% corrective actions: after the conclusion of the investigations, the following corrective actions were planned in order to reduce the risk of recurrence of similar issues: - sensitizations to the lima operators to carefully verify the full correspondence between the number of items received and the number of items declared in the documents; - modification of the lima internal work instruction (win 09-1-12, internal warehouse inventory): only dedicated job profiles will be able to perform inventory adjustments; - introduction of the rfid technology for the warehouse and putaway areas.In addition, our supplier also implemented an action plan which includes the introduction of a specific instruction for label reprint management and a sensitization to the operators.Limacorporate will continue monitoring the market to promptly detect any further similar events and assess the effectiveness of the corrective actions introduced.

Event Description

During surgery performed on the (b)(6) 2019, the finned stem code 1304.15.220 lot #1815338 was found in the package of the stem code 1304.15.190 lot #1815351 ster.1800356.The surgeon was therefore forced to use a different size of the stem (size 20 instead of size 19, code: 1304.15.200), because in hospital there was only one smr series.According to the information received, the surgeon was satisfied with final implant stability.This issue prolonged the surgery of 20 minutes.Event occurred in (b)(6).

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: SMR CEMENTLESS FINNED STEM (HSD-KWT)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8979166
• MDR Text Key: 195949451
• Report Number: 3008021110-2019-00100
• 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
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1304.15.190
• Device Lot Number: 1815351
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization