MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA CERAMIC TAPER LINER, SIZE JJ/36 I.D. WITH 54MM O.D. SIZE JJ SHELL; HIP PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Arthralgia (2355); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: therapy date: date of explantation (b)(6) 2021.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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

It was reported that the patient underwent a revision surgery due to liner fracture.Patient fell during reeducation.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that the patient underwent tha on (b)(6), 2021, whereby an avenir stem, biolox delta insert, biolox delta head and continuum modular cup were implanted.In the morning of (b)(6), 2021, the patient's hip cracked upon standing up.The patient was able to walk a few steps with difficulty at the beginning, then intense pain afterwards.This led to the patient going to the er on (b)(6), 2021 at the end of the day and a partial revision surgery being carried out on (b)(6), 2021, whereby the head and liner were replaced.During the patient's rehabilitation following the tha on (b)(6), 2021, there is a notion of a fall during rehabilitation: fell from the bike at the physio.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the complaint product was returned for investigation.A visual examination was performed and the reported event can be confirmed; the ceramic liner has fractured approx.Through the center, producing two bigger fragments.Additionally, smaller fragments have been provided.However, when holding the larger fragments together, it is obvious that some additional pieces are missing and were not received for investigation.The whereabouts of these missing pieces are unknown.The entire surface including the rim are covered with several metallic smearing.The liner's taper does not show the commonly observed seating pattern indicating a proper seating in the shell.However, with not all fragments of the liner being provided, a clear assessment in this regard can not be made.Refer to the attached pictures below.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Conclusion: it was reported that the patient underwent tha on (b)(6), 2021, whereby an avenir stem, biolox delta insert, biolox delta head and continuum modular cup were implanted.In the morning of (b)(6), 2021, the patient's hip cracked upon standing up.The patient was able to walk a few steps with difficulty at the beginning, then intense pain afterwards.This led to the patient going to the er on (b)(6), 2021 at the end of the day and a partial revision surgery being carried out on (b)(6), 2021, whereby the head and liner were replaced.During the patient's rehabilitation following the tha on (b)(6), 2021, there is a notion of a fall during rehabilitation: fell from the bike at the physio.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).Neither x-rays nor any medical documents were received.Additionally, no information pertaining to the concomitant products such as the product identification, photos or the product itself were received.The condition of these products therefore remain unknown.The only product received is the fractured ceramic insert.Based on the liner being received, the reported event can be confirmed.The ceramic liner has fractured approx.Through the center, producing two bigger fragments.Additionally, smaller fragments have been provided.However, when holding the larger fragments together, it is obvious that some additional pieces are missing and were not received for investigation.The entire surface including the rim are covered with several metallic smearing.The liner's taper does not show the commonly observed seating pattern indicating a proper seating in the shell.However, with not all fragments of the liner being provided, a clear assessment in this regard can not be made.Refer to the attached pictures below.It was mentioned that the patient had a fall event during rehabilitation, whereby the patient fell from the bike at the physio.However, if and to what extent the reported fall event contributed to the inlay fracture remains 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.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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).

• Brand Name: BIOLOX DELTA CERAMIC TAPER LINER, SIZE JJ/36 I.D. WITH 54MM O.D. SIZE JJ SHELL
• 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: 13247140
• MDR Text Key: 283751018
• Report Number: 0009613350-2022-00025
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• 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: 2953501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization