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

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

Event Description

It was reported: "the inlay could not be placed in the acetabulum.The surgeon used a new inlay, which fitted.No patient injury occured, there was a delay of approx.15 minutes." the event occurred on (b)(6) 2016.Additional information has been requested and is currently not available.

Manufacturer Narrative

A technical investigation was not possible to be performed, as the device(s) were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Trend analysis: no trend identified.Device history records (dhr) review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that the inlay could not be placed in the acetabulum.As a result of that, the surgeon tried a second inlay, which fitted.There was no patient injury, but a delay of approx.15 minutes.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: visual examination: no visual examination possible as no products were returned for investigation.Review of product documentation: compatibility: no compatibility check can be performed as only one product has been reported.Inspection planning: inspection plan: characteristic feature "diameter 50.69 +0.05/-0.05 mm" with scope of testing: aql 1.0; characteristic feature "diameter 50.63 +0.05/-0.05 mm" with scope of testing: aql 1.0; characteristic feature "dimension 23.8 +0.05/-0.05 mm" with scope of testing: aql 1.0; characteristic feature ¿diameter 18.5 +0.05/-0.05 mm¿ with scope of testing: aql 1.0; surgical technique: the surgical technique states ¿the supplied insert is attached to the setting instrument, introduced into the cleaned shell, and is carefully centered.The polyethylene peg must be centred in the hole of the polar screw.To do this, use the setting instrument to position the insert at the entrance plane of the shell.In this position, the insert is turned clockwise using the setting instrument.If it can easily be turned concentrically, it is only tapped lightly with a hammer.¿ root cause determination using dfmea: failure of connection between shell and insert due to insufficient snap geometry.=> not possible: the snap geometry was checked in and a systematic issue related to potential design would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance.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, as no product was sent back for investigation.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, as no product was sent back for investigation.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).=> possible, as no specific information about the other involved products was provided.Failure of connection between shell and insert (wrong pairing) due to wrong selection of parts due to unknown compatibility list.=> not possible: it is stated that an other inlay could be implanted into the shell.Failure of connection between shell and insert due to wrong assembly procedure.=> possible: no specific information was provided related to the applied surgical technique.Conclusion summary: the questioned insert was not returned for investigation.That being said, no product investigation could be conducted.However, inspection plan ensure proper inspection of the critical dimensions.Also, the reviewed device history records did not show any abnormalities and confirm that the product was released without any discrepancies.Considering the applicable dfmea, a possible misuse/wrong implantation technique might be the reason for the reported event.If the inlay 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 surgical technique states on how to center the inlay correctly prior to impaction.Also, it is possible that the soft tissue and/or debris located between insert and cup prior to implantation which made a solid placement of the insert impossible.However, based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4)considers this case as closed.

• Brand Name: DURASUL, ALPHA INSERT, KK/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: 6185141
• MDR Text Key: 62708028
• Report Number: 0009613350-2016-01459
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.411
• Device Lot Number: 2865485
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• 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