MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA CERAMIC TAPER LINER, SIZE JJ; HIP PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/07/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to fracture of the ceramic liner and pain.The ceramic liner and the ceramic head were revised approximately 1 year and 10 months post-implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10: tprlc 133 fp 12/14 pps ho 14.0; ref#(b)(4); lot#7011714.Delta cer fm hd 036/0mm 12/14; ref#(b)(4); lot#3085264.Continuum tm shell clust 54 jj; ref#(b)(4); lot#64819004.G2- greece.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient underwent initial right total hip arthroplasty on (b)(6) 2021.Subsequently, the patient felt a crack in the hip with concurrent limb shortening.X-rays revealed damage to the prosthesis.The patient was revised on (b)(6) 2023; during which, the ceramic insert was found in pieces.The head and liner were exchanged without complication.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The reported biolox delta liner as well as the biolox delta femoral head were returned to the product surveillance team for examination.The reported event of liner fracture can be confirmed.The liner has fractured into several bigger sized fragments and multiple smaller sized fragments.Of note, not all fragments were returned.A large portion of fragments was not returned.This could have shown more of the taper area of the liner and thus possibly provide more insight to the seating of the liner.Metallic smears can be seen on the fracture surface of the fragments and on the articulation surface of the head, both occurred after the fracture.It cannot be determined if the other metallic smears seen on the fragments occurred during impaction or after the fracture.The usual seating pattern of the head can be seen in the taper connection.A review of the device manufacturing records and raw material certificate confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records in the form of surgical reports for implantation dated on (b)(6) 2021 and for the revision surgery dated on (b)(6) 2023 including the respective implant stickers were provided and reviewed by a health care professional.The review identified nothing conspicuous and no intraoperative complications during implantation or revision surgery.The patient being obese at the time of occurrence is considered as a potential contributing factor to the reported event.No radiographs were provided.A review of the ifu (valid at the time of manufacturing) mentions under subsection "contraindications" the following: "do not implant this device in obese patients because loading on the ceramic components may lead to fracture or loss of fixation." the reported event of a fracture of the ceramic liner can be confirmed on the basis of the received devices.Nothing conspicuous that could point to any contributing factors leading to the fracture could be identified during the examination of the received devices.It is of note that not all fragments of the liner were returned, which could possibly provide more information about the seating of the liner within the shell.The review of the surgical notes showed that the patient was obese at the time of event occurrence.According to the ifu of the ceramic liner and under ¿contraindications¿, the implant should not be implanted in obese patients, because loading on the ceramic components may lead to a fracture or loss of fixation.However, the reason for the liner fracture could be multifactorial, with contributing factors possibly coming from the patient, the implant or the surgical procedure.Therefore, based on the available information, we were not able to identify an exact root cause.No corrective, preventive or field action was taken following the investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA CERAMIC TAPER LINER, SIZE JJ
• 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: 17841747
• MDR Text Key: 324548478
• Report Number: 0009613350-2023-00544
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024429918
• UDI-Public: (01)00889024429918(17)310701(10)3072334
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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: 00-8775-011-36
• Device Lot Number: 3072334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 128 KG