MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALPHA INSERT, PE, HOODED, II/28; HIP PROSTHESIS

Model Number N/A

Device Problems Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Concomitant medical products: fitmore, shell with screw cones, uncemented, 52/ii; catalog#: 01.00024.552; lot#: 2365795.Therapy date: (b)(6) 2021.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.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.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

Patient was implanted on the left side and underwent a revision surgery due to osteolysis from polyethylene wear.Tm modular cup and liner were implanted during the revision surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient was implanted with a left total hip replacement on (b)(6)2004 and underwent a revision surgery on (b)(6) 2021 due to suspected osteolysis from polyethylene wear.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: two radiographs were received, one pelvic overview and one left hip ap view from (b)(6) 2020.On the left hip view, radiologically visible fracture of the fitmore shell at the medial rim and potential osteolysis at the shell bottom and the lateral rim.Images: in total 4 photographs of the removed fitmore shell and one image of the removed liner was obtained.The fitmore shell is lying on a white surgical drape and around two-thirds of the outer surface is visible.A consecutive part, consisting of around one-third of the sulmesh is missing, and the remaining sulmesh has reddish and blackish tissue attached.The visible screw cone has a scratch.The inner surface of the shell has some scratches and the polar thread appears worn.Both antirotation pins appear intact.The image depicting the inner surface of the liner shows three impaction holes filled with reddish tissue/liquid, prominent scratches and indents, especially on the rim, and a yellowish discolored articulation surface with a reddish hole that appears to be from a screw.Product evaluation: explanted items were discarded as per hospital policy; therefore, visual evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination (fitmore shell and liner) was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implanted with a left total hip replacement on (b)(6), 2004 and underwent revision surgery on (b)(6), 2021 due to debonding of the sulmesh from the fitmore shell and suspected osteolysis from polyethylene wear.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the received radiographs and images debonding of the sulmesh can be seen.Around one-third of the sulmesh is torn off.However, since the complete follow-up of x-rays is not available for evaluation, it can only be assumed that at one point in time the shell was only partially anchored in the bone and started to migrate.During the dynamic migration process of the cup, the well anchored and in the bone integrated part of the sulmesh could not follow the motion of the cup.This led to debonding and tearing of the sulmesh from the shell.Since the reasons for the debonding of the sulmesh could be multifactorial, with contributing factors from the patient, the implant and the surgical procedure, it is unknown why and at what point in time the shell started its migration.Further, due to the unavailability of the devices, the reported polyethylene wear could not be assessed.Therefore, based on the given information, exact causes for the reported events could not be identified.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: ALPHA INSERT, PE, HOODED, II/28
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11588585
• MDR Text Key: 242916591
• Report Number: 0009613350-2021-00152
• Device Sequence Number: 1
• Product Code: KWY
• 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
• Report Date: 10/07/2021

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: Lay User/Patient
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 01.00010.309
• Device Lot Number: 2367018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention