MAUDE Adverse Event Report: ZIMMER GMBH ALLOFT-S ALLOCLASSIC SHL 60 MM; ALLOFT-S ALLOCLASSIC SHELL

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: durasul, alpha insert, hooded, mm 32, catalog no#: 0100013513, lot#: 2791062.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

Patient bone was damaged when the allofit cup was explanted.

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.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: 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: bone damage due to cup removal event description: it was reported that the allofit acetabular cup was implanted.After opening the inner packaging of the durasul alpha insert there were 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 decided to remove the implanted allofit acetabular cup.An alternate implant tm (trabecular metal) acetabular cup with the corresponding insert was implanted.The patient's bone was a little damaged due to this process.Review of received data: - 5 images were received (allofit1 thru allofit5).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, however, 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 water drops can be recognized, however, image quality is rather poor.Image allofit4 shows the allofit insert on a blister attachment and the product sticker with product reference number (b)(4).Image allofit5 shows the inner surface of the allofit shell with the product sticker with product reference number (b)(4).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.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Conclusion: it was reported that the allofit acetabular cup was implanted.After opening the inner packaging of the durasul alpha insert there were 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 decided to remove the implanted allofit acetabular cup.Tis issue regarding insert contamination by unknown particles is covered in (b)(4).An alternate implant tm (trabecular metal) acebaular cup with the corresponding insert was implanted.The patient's bone was a little damaged due to this process.This complaint (b)(4).Covers the bone damage that occurred due to the intraoperative removal of the allofit cup.Based on the given information the allofit cup had to be removed intraoperatively right after its implantation due to the lack of a mating allofit insert.As the only available mating allofit insert could not be used due to potential foreign particles there was no mating insert available for the implanted allofit cup.Therefore, the allofit cup had to be removed and replaced by another acetabular system.During removal of the allofit cup the patient's bone was a little damaged.However, no surgical notes, intraoperative images or x-rays were received that describe or show the degree of bone damage.The quality records of the allofit cup show that all specified characteristics have met the specifications valid at the time of production.Therefore, based on the given information no product issue of the allofit cup was identified and the root cause for the damaged bone can be related to the mechanical manipulation during the cup removal.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

Please refer to report 0009613350-2018-01083.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: devices analysis visual examination of the shell performed and cratches are visible which were due to removal forces applied.No particular deformation is observed.No change in the investigation result and root cause.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)(6).

Event Description

Please refer to report 0009613350-2018-01083-2.

• Brand Name: ALLOFT-S ALLOCLASSIC SHL 60 MM
• Type of Device: ALLOFT-S ALLOCLASSIC SHELL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7978275
• MDR Text Key: 124128258
• Report Number: 0009613350-2018-01083
• Device Sequence Number: 1
• Product Code: MDM
• 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,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00000004269
• Device Lot Number: 2832305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization