MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC SL STEM 5 12/14; ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

Model Number N/A

Device Problem Difficult To Position (1467)

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

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted an alloclassic sl stem 5 12/14 on (b)(6) 2017.During this surgery after the rasping, the surgeon inserted this stem, but couldn't insert into the desired position.This surgery was finished with size 4 stem.

Manufacturer Narrative

Additional information has been requested and is currently not available.No trend considering the following event is identified: stem not sitting in the correct position (intraoperative).Event summary: an alloclassic stem, size 5 (ref: 2845 lot: 2910863) has been received.It has been reported that after the rasping, the surgeon inserted the stem, but couldn't insert into the desired position.The surgery was then finished with a stem size four.Review of received data no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis - visual examination: the alloclassic stem, size five, shows some scratches in the proximal part of the stem.Further no considerable deteriorations, deformations or imperfections can be seen.- measurements: to ensure the insert has correct dimensions, relevant characteristic were measured.Further the dhr indicates that the stem met all specifications.Root cause analysis root cause determination using rmw: - intraoperative complications due to incorrect associated instruments used => possible, as the surgeon might have used an incorrect rasp size or even a wrong type of rasp.- intraoperative complications due to design specification not met.-> not possible, a systematic issue with design would have been detected as part of the issue evaluation assessment.Further the dhr of the reported stem indicates that the stem met all specifications.- intraoperative complications due to missing component in set package -> not possible as nothing indicates a component was missing.- intraoperative complications due to inadequate handling during transport/storage -> not possible as nothing indicates the reported issue is related to inadequate handling during transport/storage.- intraoperative complications due to incorrect rasping direction => possible, as an incorrect rasping direction might have caused the improper initial positioning of the stem size 5.- intraoperative complications due to excessive extraction force due to wrong instruments -> not possible as the reported event is not related to any extraction forces.- intraoperative complications due to wrong usage of instruments => possible, as the surgeon might have used an incorrect rasp size or even a wrong type of rasp.- intraoperative complications due to excessive attachment force -> not possible as the reported event is not related to any attachment forces.- intraoperative complications due to wrong handling of instrumentation => possible, as a wrong handling of the rasps (e.G.Wrong rasping direction) might have caused the improper initial positioning of the stem size 5.- inadequate implant positioning due to inappropriate information on packaging label or not legible packaging label leads to incorrect use of implant => possible, as confusion regarding the size of the reported stem or the rasped used might have caused the reported event.- intraoperative complications due to inappropriate information on packaging label or not legible packaging label leads to incorrect use of implant => possible, as confusion regarding the size of the reported stem or the rasped used might have caused the reported event.- intraoperative complications due to insufficient description of surgical process leads to intraoperative errors or misuse of implant outside of its scope not possible -> as the surgical technique alloclassic zweymueller stem describes the relevant surgical process steps (rasping and insertionof the implant).Conclusion summary based on the returned product and the given information the complaint could not be confirmed.The visual examination and the measurement did confirm that the dimension of the stem are conforming.Further the quality records for the reported stem show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The surgeon might have used an incorrect rasp/ stem size combination.As according to the reported event the surgery could be completed with a stem size four, the surgeon most likely rasped up to size four, making a correct positioning of the stem size 5 impossible.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer`s reference number of this file is (b)(4).

• Brand Name: ALLOCLASSIC SL STEM 5 12/14
• Type of Device: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 6964149
• MDR Text Key: 90675040
• Report Number: 0009613350-2017-01470
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: P030373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

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 Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 2845
• Device Lot Number: 2910863
• Other Device ID Number: 00889024481367
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 01/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1