MAUDE Adverse Event Report: ZIMMER GMBH DURASUL®, ALPHA INSERT, HH/32; ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS

Model Number N/A

Device Problem Misassembled (1398)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The actual device reported is not marketed in usa, but devices with similar characteristics (i.E durasul alpha insert neutral ii/32) are marketed in usa, and therefore this report was filed.Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it is reported that the insert was loose and rotating inside the allofit shell.The surgeon was not able to seat the liner into the shell.For several times he tried but it was unsuccessful.He suspected that there was a problem with allofit shell.Surgery was completed with a cemented shell and it was delayed by 60 minutes.No medical data such as x-rays, surgical notes or any other case-relevant documents received.To ensure the insert has correct dimensions, the relevant characteristic according to the inspection plan were measured and compared with the respective drawing.The conducted measurements confirm the correct size of the affected liner.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.The surgical technique for allofit/allofit-s alloclassic acetabular system states, that ¿clean and dry the inner surface of the shell, connect the liner to the setting instrument, position the liner over the entrance plane of the shell and rotate clockwise.The peg of the polyethylene liner must be inserted into the pole plug hole.Complete seating of the liner with a light hammer blow.If the liner can still be rotated after light impaction, this indicates mispositioning, nonconcentric, or soft tissues interference between the liner and the shell surfaces.In such situation, remove the liner, clean both surfaces and introduce the liner back into the shell, making sure it is properly centered and repeat the seating procedure.Once the liner remains steady after light hammer blows, finalize seating with final impaction.Where necessary, a tap plastic impactor provides confirmation that the connection is reliable.If the insert has snapped into place correctly, the edge is protruding around 1.5 mm over the equator of the titanium shell note: if unsure, the seating can be checked using a raspatory.If the fitting of the insert is faulty, a new insert must be used.If the polar peg is deformed, it will not be possible to anchor the insert correctly.¿ raw material certificates of the device were reviewed and it is confirmed that the devices were manufactured according to the material specifications.Root cause analysis - difficulties to assemble insert due to high load due to impaction during the primary implantation or revision leading to damage of the polar plug => possible: the polar plug is not received, therefore cannot be excluded.- difficulties to assemble insert due to high load due to impaction during the primary implantation or revision leading to damage of the polar thread of the shell => possible: polar hole thread of the shell is damaged.- difficulties to assemble insert due to high load due to impaction during the primary implantation or revision leading to fracture of the pelvis => not possible: as no pelvis fracture is reported.- failure of connection between shell and insert due to wrong pairing of components (wrong size) => not possible: the paired components have correct sizes.- failure of connection between shell and insert (wrong pairing) due to wrong selection of parts due to unknown compatibility => not possible: the paired parts are compatible with each other.- failure of connection between shell and insert due to wrong assembly procedure => possible: damages (deformed peg on the insert, unpaired indents due to the two pins of the shell, grooves, scratches) indicate the insert was not centered correctly within the shell prior to impaction with the hammer.Conclusion summary: review of the dhr indicate that the devices met all requirements to perform as intended.Moreover, the correct size can be confirmed.No problems related to shell or insert were observed.Raw material certificates of the devices also certify the material specifications.The observed damages (deformed peg on the inlay , two significantly big indents, cuts, dents and marks) indicate an experienced difficulty with centering the insert within the shell prior to impaction.Seemingly, high impaction and torque forces acted on the inlay and several tries were performed to anchor the insert.Further the deep grooves indicate the insert was rotated on the spikes of the shell.The insert should not be rotated within the shell, once it is impacted.If the insert gets impacted without being correctly centered, the centering peg gets deformed and expanded making it subsequently even more difficult to achieve a correct position and an anchoring of the inlay.The correct way to seat the inlay within the shell is explained in the surgical technique.Further possible causes for the reported failure include the slight deformation of the metallic shell due to the very hard bone conditions, soft tissue and/ or debris left between insert and cup prior to seating and storing the insert in a rather cold place which might lead to a slight decrease of the outer diameter (material reduction).However, it is not known to which extent these factor have played a role in the observed event.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).

Event Description

It was reported that during primary surgery with allofit shell, the surgeon was not able to fit the durasul®, alpha insert, hh/32 into the shell as it was loose.The surgery was completed with a cemented shell and a delay of 60 minutes.

• Brand Name: DURASUL®, ALPHA INSERT, HH/32
• Type of Device: ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
• 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: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6614574
• MDR Text Key: 76751918
• Report Number: 0009613350-2017-00767
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.408
• Device Lot Number: 2786342
• Other Device ID Number: 00889024413603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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): Other