MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURIG GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 40/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Ossification (1428); Death (1802); Unspecified Infection (1930); Scar Tissue (2060); Sepsis (2067); Joint Dislocation (2374); Impaired Healing (2378); Paraplegia (2448); Swelling/ Edema (4577)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products: item: modular femoral stem, catalog #: 00771301200, lot #: 63346813.Item: shell with multi holes, catalog #: 00875705802, lot #: 63290513.Item: unknown liner, catalog #: unknown, lot #: unknown.Item: modular neck x 12/14 neck, catalog #: 00784801400, lot #: 61956654.The manufacturer did not receive x-rays, or other source documents for review.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.(b)(4).

Event Description

It was reported that a patient underwent a total hip arthroplasty.Subsequently, it is alleged that the patient became partially paralyzed and began experiencing signs of infection within one month post-operatively.The hip also allegedly "fell apart" approximately three months post-operatively.The patient underwent revision due to infection approximately seven months post implantation of the total hip arthroplasty.Dark metal stained fluid was noted and removed during the revision.The patient eventually passed away, following continued bouts with infection.

Event Description

No change to previously reported event.

Manufacturer Narrative

Event summary: it was reported that a patient underwent a total hip arthroplasty.Subsequently, it is alleged that the patient became partially paralyzed and began experiencing signs of infection within one (1) month post-operatively.The hip also allegedly fell apart approximately three (3) months post-operatively.The patient underwent revision due to infection approximately seven (7) months post implantation of the total hip arthroplasty.Dark metal stained fluid was noted and removed during the revision.The patient eventually passed away, following continued bouts with infection.At the time of death, the medical examiner concluded that the patient died from infection.Other doctor mentioned urosepsis, paraplegia, bacterial meningomyelitis and right hip arthroplasty for right femoral neck fracture as cause of death.Review of received data - no medical data such as x-rays, surgical notes or any other case-relevant documents received.- review of statement given by patients significant other: a 65-year-old man was implanted on the right side with trabecular shell, ml tapered hip prosthesis, femoral head, modular neck.In the surgery the surgeon apparently left a washer inside the patient.Two week after implantation there were signs of infection.Patient woke up paralyzed from t3 downwards.A revision followed in 2017.During this procedure, surgeon removed 5 ml of dark metal-colored liquid.Until 2018 the patient had to fight several infections.At the time of death, the doctor concluded that the patient died from infection.The medical examiner mentioned urosepsis, paraplegia, bacterial meningomyelitis and right hip arthroplasty for right femoral neck fracture as cause of death.- no further due diligence required as all required information to support the conclusion is available or was already requested.Devices analysis - no product was returned to zimmer biomet for in-depth analysis.Review of product documentation - this device is intended for treatment.- the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.- dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.- sterilization certificate was reviewed on 10-jun-2020 and showed that the device has been treated, according to the following standards: - iso 9001, iso 13485, iso 11137.21cfr part 820 (fda c gmp).The sterilization certificate was reviewed with no deviations / anomalies identified.Conclusion summary it was reported that a patient underwent a total hip arthroplasty.Subsequently, it is alleged that the patient became partially paralyzed and began experiencing signs of infection within one (1) month post-operatively.The hip also allegedly fell apart approximately three (3) months post-operatively.The patient underwent revision due to infection approximately seven (7) months post implantation of the total hip arthroplasty.Dark metal stained fluid was noted and removed during the revision.The patient eventually passed away, following continued bouts with infection.At the time of death, the medical examiner concluded that the patient died from infection.Other doctor mentioned urosepsis, paraplegia, bacterial meningomyelitis and right hip arthroplasty for right femoral neck fracture as cause of death.No medical data such as x-rays, surgical notes or any other case-relevant documents received and no product was returned to zimmer biomet for in-depth analysis.However, the quality records were reviewed and show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).Additionally, the sterilization certificate was reviewed and showed that the device has been treated according to the applicable standards with no deviations / anomalies identified.Therefore, it can be excluded that an unsterile device caused the infection.Moreover, no trend on infection has been observed for this product family.Therefore, with the available documentation it seems unlikely that the head contributed to sepsis, paraplegia or bacterial meningomyelitis leading to the patient's death.Further it is stated by the patient's significant other that a washer was left inside the patient.It remains unknown if and to what extend this might have contributed to the infections.Nevertheless, an infection can have numerous root causes.Possible causes of infection include wrong handling of device during transportation and /or storage, contaminated device due to packaging failure and additional patient and surgical factors which remain unknown.Therefore, based on the investigation and the available information, we were not able to identify an exact root cause for this issue.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 cmp-0554000.

Event Description

Medical records were received and reviewed therefore this complaint was reopened and its corresponding investigation updated.

Manufacturer Narrative

Medical records received.1.Event description: it was reported that an initial right total hip arthroplasty performed (b)(6) 2016.Upon follow up, it was noted that the patient had some lateral redness in a well-approximated, almost healed incision.The patient was placed on oral antibiotics and instructed to return in one week for follow up.Upon return, it was noted that the incision was completely healed.No further complications were reported concerning the incision.Approximately one month later, the patient experienced a mid-thoracic complete spinal cord injury and myelomeningitis resulting in urosepsis and paraplegia.While in the rehab hospital, it was noted on x-ray that the patient¿s hip arthroplasty components had disassembled.All hip aspirations were negative for infection; however, the surgeon wanted to revise due to increased swelling.During the revision that occurred on (b)(6) 2017, some heterotopic ossification was noted and 5ml of dark stained fluid was aspirated from the joint.No obvious signs of infection were noted.All components were removed without complication, and antibiotic cement beads were placed.The patient continued to experience ongoing infections until he died in 2018.Harm: s3 - dislocation, s3 - swelling hazardous situation: properly placed implants do not accurately restore the patient's kinematics and/or anatomy.2.Review of received data: x-rays: the provided x-ray was assessed but was not sent for further analysis due to poor image quality and the event is adequately described in revision dictation.Medical records : the provided medical records were reviewed by a health care professional and identified the following: on (b)(6) 2016, the incision was noted to be almost completely healed with some lateral incision redness.The patient was prescribed keflex and bactrim for prophylaxis.The patient also reported intermittent pain and concerns about his right foot turning inward, for which he was instructed to increase strength.On (b)(6) 2016, the distal incision was completely healed with slight erythema however that is much improved since the last week.X-rays from the (b)(6) 2016 showed soft tissue swelling and x-rays from (b)(6) 2016 showed development of heteroptopic ossification of the surrounding soft tissue and soft tissue edema.From rehab notes from (b)(6) 2016, the patient had an aspiration of his right hip which did not show any signs of infection.A ct scan showed a disassembled right hip arthroplasty along the intertrochanteric component.The notes for the hip implant removal indicates the patient had 2 joint aspirations with no signs of infection.The x-ray showed the modular neck had disassociated form the femoral stem and the hip was dislocated.Disassociated/dislocated components were removed.3.Conclusion: based on the investigation the reported event can be confirmed.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).It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.As reported the patient's surgical wound site/incision had some abnormal or unexpected redness.This deviation signifies an alteration in the wound healing process.The patient had several comorbidities such as elevated bmi, cardiovascular, and liver disease that would have contributed to this event.The root cause of the delayed wound healing is hence determined to be not related to the implanted zimmer biomet devices.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the dislocation issue.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).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 40/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURIG 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: 9290820
• MDR Text Key: 165425674
• Report Number: 0009613350-2019-00654
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430402
• UDI-Public: 00889024430402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-040-02
• Device Lot Number: 2823276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 06/11/2020; 11/30/2021
• Supplement Dates FDA Received: 06/24/2020; 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• 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; Death