MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE CUP HIP IMPL WIN; HIP PROSTHESIS.

Model Number N/A

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.As no lot numbers were provided the device history records couldn't be reviewed.The process of gaining necessary information is still ongoing.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 was implanted on an unknown side and underwent revision sue to mesh dissociation from the shell.

Manufacturer Narrative

Event description: it was reported that the patient underwent right total hip arthroplasty 30 years ago and had a revision surgery on (b)(6), 2021 due to fitmore shell loosening with a delamination of the sulmesh coating.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 preoperative x-rays dated (b)(6), 2020 were received, whereby one of the images is an ap view and the other is a lateral view of the right hip.The ap view is over-penetrated but shows a debonding of the sulmesh and a migrated and tilted shell.The lateral view is of poor quality and doesn't offer a clear assessment of the femoral head or acetabular components.No additional x-rays such as post-implantation or over the course of the reported 30 years have been received.Additionally, the ap x-ray was reviewed by an external radiologist (hcp), whereby the following assessment was made: the single image is limited by overpenetration of the hip.The acetabular mesh appears displaced from the shell and the prosthetic femoral head appears subluxed superiorly.No fracture is identified.Bone quality is osteopenic.- images: three intraoperative images were received showing the explanted components.One of the images shows the metasul liner still assembled with the fitmore shell, with a large chip damage (about 1/4 of the surface area, excluding the articulation surface) on the anterior surface around the articulating surface.Tissue and blood stains as well as signs of metalosis on the articulating surface are also present.The second image shows the posterior side of the fitmore shell with two screws inserted in the holes, of which one of the screws is fractured off around the area of the screw head.There is a large size dent below this screw hole, but smaller in diameter than the screw hole.A very large portion of the sulmesh on the shell is missing, but could be extracted from the surgical site, as evident in the picture.The sulmesh still present on the fitmore shell do not show any bone attachment.On the sulmesh which was extracted, there is tissue still adhering to it as well as signs of metalosis.However, there are also areas on the extracted sulmesh where little to no traces of tissue can be seen.The explanted pfm stem is assembled with the femoral head.No apparent damages can be seen on the femoral head from this picture.However, on the neck of the stem, close to the femoral head, there is a deep notching, possibly due to impingement with the shell, and which possibly resulted in the chip damaged as described on the metasul insert.The last image provided is of the pfm stem with the femoral head as well as the fitmore shell.No additional observations can be made other than previously described.- patient data: (b)(6)1944, f - the implant record of the implanted products during the revision surgery on (b)(6), 2021 has been provided.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - document review could not be performed due to unknown product identification.- device purpose: all involved devices are intended for treatment.- product compatibility: the compatibility check could not be performed due to missing product identification.- ie/capa/hhe(d) search: the search identified a capa for the failure more of debonding of the sulmesh from the titanium substrate.As part of this capa, the manufacturing process was improved (diffusion bonding) to strengthen the sulmesh connection with the shell, ensuring a better force transmission between the sulmesh and the shell, leading to a stress reduction in the sulmesh.Conclusion: it was reported that the patient underwent right total hip arthroplasty 30 years ago and had a revision surgery on (b)(6), 2021 due to fitmore shell loosening with a delamination of the sulmesh coating.The manufacturing records could not be reviewed due to no product identification provided and no products being returned.Nevertheless, based on the given information there is no indication of a nonconformance or complaint out of box (coob).Three images were provided showing the explanted products.Of note is the large chip damage (about 1/4 of the surface area, excluding the articulation surface) on the anterior side of the metasul insert as well as a very large portion of the sulmesh on the shell missing.There is only very little remaining sulmesh on the shell and it does not show any bone attachments.One part of debonded sulmesh was received and exhibits good bone ingrowth.One of the two screws still contained within the shell is fractured off around the screw head.Additionally, there is a deep notching on the neck of the pfm stem, which possibly resulted from shell impingement with the stem.However, it is unknown if this was favored by the rather steep inclination angle of the shell after its migration or if it occurred already before the migration.Nonetheless, all these above mentioned phenomena can likely be attributed to the reported event.Based on the received x-rays the reported event can be confirmed.However, no additional x-rays directly post-implantation or over the course of the 30 years have been received.Therefore, it is assumed that at one point in time the fitmore shell was only partially anchored in the bone and started its migration.During the dynamic migration process of the shell, the well anchored and in the bone integrated part of the sulmesh likely could not follow the motion of the shell.This would have likely led to debonding and tearing of the sulmesh from the shell.However, the exact reason as well as the exact point in time that the shell started its migration remain unknown.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.However, the reported event most probably is related to a previous capa.As part of this capa, the manufacturing process was improved to strengthen the sulmesh connection with the shell.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: FITMORE CUP HIP IMPL WIN
• Type of Device: HIP PROSTHESIS.
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12546528
• MDR Text Key: 273770285
• Report Number: 0009613350-2021-00506
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention