MAUDE Adverse Event Report: ZIMMER GMBH DURASUL CLS SPOTORNO, INSERT, 58/32

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation is pending.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient underwent revision surgery on (b)(6) 2017 to replace the inlay on the right side.The new inlay could not be inserted, therefore another cup was used instead.The inlay was not implanted.

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event was identified: durasul inlay could not be inserted in to cup review of event description: a cls durasul inlay, size 58/32 (ref:01.00307.458; lot:2860805) has been received.It has been reported that during a revision the new returned inlay could not fit in the still implanted cls cup.The surgeon stated that he could not fit the inlay because it has another design.As a result, the operation was completed with another cup system.Review of received data: four x-rays have been received.Two show the situation before the revision with the cls cup and inlay still implanted.The other two show the revised hip.Based on the two later x-rays it can be confirmed that finally also the cls cup was removed and another cup system applied.Devices analysis: the durasul inlay, size 58/32 (ref:01.00307.458; lot:2860805) which according to the surgeon could not fit in the cup has been returned.Visual examination: the front ring area presents multiple scratches and a imprint from the setting device instrument can be seen.Most noticeable is the damaged thread on the outer surface which shows plastic shavings all around the thread in the upper area.Measurements: to ensure the durasul inlay, 58/32 (ref:01.00307.458; lot:2860805) has correct dimensions, the relevant characteristic according to the inspection plan were measured.Characteristic no.1 feature ¿diameter 33.1 +0.1/-0.1¿ -specification: max.33.20mm; min.33.00mm -measured value: 33.03mm -conclusion: the ball diameter of the insert can be confirmed.Characteristic no.3 feature ¿diameter 39.00 +0.05/-0.05¿ -specification: max.39.05mm; min.38.95mm -measured value: 39.03mm -conclusion: the diameter of the insert can be confirmed.Characteristic no.6 feature ¿dimension 29.275 +0.075/-0.075¿ -specification: max.29.35mm; min.29.2mm -measured value: 29.25mm -conclusion: the height of the inlay can be confirmed.Further the dhr indicates that all components met all specifications.Functional tests: no functional tests can be conducted as the part shows several damages/ imperfections.Review of product documentation: compatibility: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Inspection planning: inspection plan: - characteristic no.1 feature diameter 33.1 +0.1/-0.1 with scope of testing: 20%; means of inspection: innenkugellehre, - characteristic no.3 feature diameter 39.00 +0.05/-0.05 with scope of testing: 10%; means of inspection: instrumentlehre - characteristic no.6 feature dimension 29.275 +0.075/-0.075 with scope of testing: 20%; means of inspection: höhenmessgerä.Surgical technique: the surgical technique ed.2010-12 page 13 states: "by turning the expansion cone in the counterclockwise direction, the screw canal can be correctly filled without applying force.Then, maximum expansion is achieved by turning in the clockwise direction, while keeping the knob on the handle pressed.By turning in the counterclockwise direction, the instrument can be removed." page 14 states: ¿before the insert is placed, it must be checked whether marginal osteophytes in the acetabulum and/or possible remains of the capsule can interfere with the correct positioning of the insert." drawing: a review of the drawing show that the design of inlay 01.00307.458 has not been changed since 2004.The relevant dimensions are similar to the cls metasul inlay 60.13.28-58 which was removed from the cls shell (see case (b)(4) for the revision surgery).Based on this observation, it cannot be confirmed that the new inlay could not fit in the cls cup due to a new design (as stated by the surgeon).Root cause analysis root cause determination using to dfmea: - malpositioning of the liners, generation of pe debris, dislocation of liner due to wrong alignment of insert in shell possible: the inlay might have been malpositioned during insertion and as a result pe shavings were generated.These shavings might have prevented a proper seating of the inlay within the shell.- failure of connection between shell and insert due to wrong selection of shell / insert due to unknown compatibility list not possible: as the revised inlay from (b)(4) and the returned inlay as reported in this complaint were compared.It can be confirmed both inlays have the same size.- damage of the cup (cause: excessive expansion during implantation / revision) due to high load due to excessive expansion possible: during the removal of the implanted inlay the thread of the cup might have been deformed/ damaged.- damage of the insert (cause: torque load during implantation) due to high load due to insertion / revision possible: during the insertion the inlay got damaged due to high load (shavings created) and could not be seated.This might have been caused due to the inlay being tilted or by a defored/ damaged shell thread.- implant failure due to damaged implant due to multiple resterilization cycles not possible: nothing indicates the reported damage was caused by multiple resterilization cycles.- increased wear due to foreign particles in articulation (bone cement, metal debris, ceramic particles) possible: after the revision of the implanted inlay small bone particles or metal debris might have remained in the articulation between the shell and the new inlay.- inadequate anatomical reconstruction of the joint, migration of shell / insert short and long term, splitting of bone, improper initial setting of the implant due to wrong size implanted (incorrect size chosen) not possible: as the revised inlay from (b)(4) and the returned inlay as reported in this complaint were compared.It can be confirmed both inlays have the same size.Conclusion summary: based on the returned product and the given information the damaged inlay could be confirmed however it could not be confirmed that the new (returned) inlay has a new design.The returned inlay with size 58/32 has been produced according specifications and the correct size can be confirmed.It remains unclear why the insert could be anchored within the shell.The detected damages of the thread on the outer surface on the returned inserts of size 58/32 indicates the surgeon had difficulties with the fixation of the insert.As no relevant design changes occurred during the time after primary surgery it can not be confirmed that the new inlay could not fit in the cls cup due to a new design.A possible root cause could be that during the revision and/or during the years implanted the cup got deformed.Further the inlay might have been tilted during the insertion or particles (bone, metal) remained in the articulating surface after removal of the implanted inlay.To prevent the deformation of the cup the surgeon could have used the expansion cone which is described in the surgical technique page 13, whether this was done is not known.After not succeeding with the insertion of the cls insert the surgeon made the correct choice by also removing the shell.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: DURASUL CLS SPOTORNO, INSERT, 58/32
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6809868
• MDR Text Key: 83220614
• Report Number: 0009613350-2017-01087
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 0100307458
• Device Lot Number: 2860805
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR