MAUDE Adverse Event Report: ZIMMER GMBH DURASUL, ALPHA INSERT, HOODED, MM 32; DURASUL ALPHA INSERT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: alloft-s alloclassic shl 60 mm, catalog no#: 00000004269; lot#: 2832305; therapy date: unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the explanted 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.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

The implant was found contaminated after opening the packaging hence the alternate implant was implanted.

Manufacturer Narrative

Additional information was received.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

No event update.

Event Description

Investigation results are available.

Manufacturer Narrative

Dhr review: ref#: 01.00013.513 lot#: 2791062 (insert), yield: 20, delivered: 20.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref#: 4269 lot#: 2832305 (shell) , yield: 50, delivered: 50.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 is identified: material contamination.Event description: it was reported that the allofit acetabular cup was implanted.After opening the inner packaging of the durasul alpha insert there was a large number of unknown particles found on the surface of the insert.The surgeon didn't want to risk the possibility of a contamination and so decided to remove the implanted allofit acetabular cup.During removal of the cup the patient's bone was a little damaged.An alternate acebaular cup with the corresponding insert was implanted.Review of received data: 5 images were received: the first two images (allofit1 and allofit2) show the white tyvek part from one of the two sterile, inner packaging pouches.On both images brownish punctiform defilements can be seen, whereupon, image allofit1 seems to be a magnification of image allofit2.Image allofit3 shows again one of the two sterile, inner pouches.On the transparent pet foil particles and what seems to be water drops can be recognized, but image quality is rather poor.Image allofit4 shows the allofit insert on a blister attachment and the product sticker with product reference number 01.00013.513.Image allofit5 shows the inner surface of the allofit shell with the product sticker with product reference number 4269.The pole plug is halfway inserted.Shiny areas around the pole thread of the cup and on the pole plug can be seen.Further, some shiny areas on the rim of the cup can be seen.Otherwise, no medical data such as surgical notes or any other case-relevant documents received.Devices analysis: visual examination: multiple images were taken in our lab during unpacking of the received devices (alofit shell and durasul insert).Particles similar to lint or particulate matter could be seen on the insert visible with naked eye.On the blister some yellowish / brownish discoloration can be seen.Review of product documentation: the compatibility check was performed and showed that the product combination (durasul alpha insert mm and allofit shell mm) was approved by zimmer biomet.The device history records and the sterilization certificate were reviewed for the insert with all preprocessing steps.The device was manufactured according to specification.Packaging specification: packaging design: standard double pouch system for eto sterilization.The product is placed into a peelable tyvek / polyester / polyethylene peel-pouch which is heat sealed.This sealed pouch is then placed into another tyvek / polyester / polyethylene peel-pouch and heat sealed creating a double barrier.Sterile package protection is afforded by a a solid folding carton and shrink film.Conclusion summary: during surgery upon unpacking of the durasul insert, countless particles were found on the device.Therefore, it was decided not to implant the insert.Instead the already implanted shell was removed and replaced by another acetabular system, as no fitting alternate insert was available that would match with this shell.The shell as well as the insert were received for investigation.During examination of the insert multiple particles were found on the blister and on the insert.However, as the package was already opened, it can no longer be traced back at which point in time the particles got on the device or inside the packaging.Especially, the yellowish / brownish discoloration may be residue from blood, body fluid or any other liquid used during surgery.The device manufacturing quality records (dhr) as well as the sterilization certificate indicate that the released component (durasul alpha insert) met all requirements to perform as intended.Further, no trend regarding material contamination was found, neither for the durasul alpha insert (ref.01.00013.513) nor for any other device within the last 6 months.Therefore, based on the investigation no manufacturing issue was 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).Note: the following case is associated with this event (same patient): (b)(4).

• Brand Name: DURASUL, ALPHA INSERT, HOODED, MM 32
• Type of Device: DURASUL ALPHA INSERT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7973160
• MDR Text Key: 123941085
• Report Number: 0009613350-2018-01085
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 0100013513
• Device Lot Number: 2791062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other