MAUDE Adverse Event Report: ZIMMER GMBH WAGNER CONE PROSTHESIS, IMPACTOR FOR TRIAL STEM; WAGNER CONE PROSTHESIS SYSTEM

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device 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 surgeon noticed several difficulties using the instrument during the surgery.This caused a delay of 3 hours and however the surgery was completed as planned.

Manufacturer Narrative

D11 concomitant medical products: item# 01.00569.010, lot# 16.333660, wagner cone prosthesis, impactor for trial stem.Item# 01.00569.115, lot# 16.244393, wagner cone prosthesis, trial stem, distal, 15.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: damaged threads.Event summary: it was reported that the wagner cone stem impactors and the screw part of the distal trial prosthesis were damaged due to which a surgical delay of more than two hours occurred.As the distal trial stem prosthesis could not be extracted with the impactor the surgeon had great difficulties to remove the trial stem prosthesis from the medullary cavity which led to the extended surgery time.No patient information is available.Review of received data: no medical data such as surgical notes or any other case-relevant documents received.Devices analysis.Visual examination: the trial prosthesis shows some normal signs of usage on the outer surface from the rim area to the tip of the trial ste.On the other hand, the threaded adapter of the proximal part of the trial prosthesis is highly deformed.Due to the massive deformation of the thread the device can no longer be used.Both trial prosthesis impactors do not show any conspicuousness on the outer surface.To check the functionality of the inner threads a functional test was performed, refer to the section functional test.Based on this visual examination the reported event can be confirmed.Measurements: no measurements were performed, as the thread of all three devices are damaged, refer to functional test.Functional test: a functional test was performed to check the functionality of both trial prosthesis impactors.A working trial stem prosthesis was used and assembled with both trial prosthesis impactors.However, for neither of the two impactors the trial prosthesis could be assembled as intended.In both cases the thread jammed before the assembly reached its final position.Based on this functional test the reported event can be confirmed.Review of product documentation: the product combination was approved by zimmer biomet.Root cause analysis root cause determination using rmw: - instrument breaks, deforms, diverges impairing its function due to inadequate design for intended performance not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Instrument breaks and parts remain in wound.Due to inadequate design for intended performance not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Instrument breaks, deforms, diverges impairing its function due to mechanical properties of material insufficient not possible, as according to material compatibility specification the material has been tested.Further, a systematic issue with material properties would have been detected as part of the issue evaluation assessment.Instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition possible, as the distal trial prosthesis could not be assembled with the trial stem impactor.Damaged instruments, implants, body or wrong operational step due to surgeon or or staff unfamiliar with instrument usage and handling => possible, as the thread of all three devices were damaged and no information about the surgery was given, this cause cannot be excluded.Damaged instruments, implants, body or wrong operational step due to surgeon or or staff unfamiliar with instrument usage and handling possible, as the thread of all three devices were damaged and no information about the surgery was given, this cause cannot be excluded.Instrument breaks or deforms due to off-label / abnormal-use possible, as the thread of all three devices were damaged and no information about the surgery was given, this cause cannot be excluded.Instrument cannot be used with the connected instrument as intended due to failure of instrument assembly condition possible, as the distal trial prosthesis could not be assembled with the trial stem impactor.Conclusion summary: it was reported that the wagner cone stem impactors and the distal trial stem prosthesis were damaged due to which a surgical delay of more than two hours occurred.As the distal trial stem prosthesis could no longer be extracted with the impactors the surgeon had great difficulties to remove the trial stem prosthesis from the medullary cavity which led to the extended surgery time.No patient information, or other case-relevant medical documents such as surgical notes were available for investigation.The quality records of all three devices show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Furthermore, the thread of both wagner cone trial stem impactors underwent multiple inspections and functional testing during and at the end of the production including inspection of the inner diameter, the thread and a functional test.The visual examination clearly shows massive deformation of the thread of the distal trial prosthesis.It can be assumed that most of the damage was done during the difficult removal of the trial prosthesis from the medullary cavity.Deformation marks indicate that the thread was clamped with a gripper.Therefore, it can no longer be distinguished between potential, original marks and marks introduced during removal.The functional test showed that also the threads of the two trial stem impactors are damaged.Therefore, it is possible that a damage of the thread of the trial stem prosthesis led to a damage of the thread of the impactors or vice versa.Potential damage to the threads may be triggered by a too high or wrong directed force (at an angle), not properly cleaned surfaces during assembly or damage during transport, storage and reprocessing of the devices.Nevertheless, based on the given information and the results of the investigation no specific root cause could be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Event Description

Please refer to initial report.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.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.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: WAGNER CONE PROSTHESIS, IMPACTOR FOR TRIAL STEM
• Type of Device: WAGNER CONE PROSTHESIS SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7766510
• MDR Text Key: 116534468
• Report Number: 0009613350-2018-00709
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK113556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0100569010
• Device Lot Number: 16.259023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other