MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804); Compatibility Problem (2960)

Patient Problems Wound Dehiscence (1154); Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Reaction (2414); Metal Related Pathology (4530)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." number 4 states, "loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Event Description

Legal counsel for patient reported patient underwent a left hip revision procedure approximately 8 years post-implantation due to alleged pain, elevated metal ion levels, metal poisoning, metallosis, metal debris, metallic-stained tissue, and dehiscence of posterior hip capsule.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Invoicing history reveals that the femoral head was removed and the patient was implanted with active articulation.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

Lab test results dated (b)(6) 2016 revealed cobalt, plasma level 19.0 ug/l and chromium, plasma level 18.2 ug/l.Lab test results dated (b)(6) 2016 revealed cobalt, plasma level 5.1 ug/l and chromium, plasma level 12.4 ug/l.Lab test results dated (b)(6) 2016 revealed cobalt, plasma level 4.6 ug/l and chromium, plasma level 11.6 ug/l.

Event Description

Legal counsel for patient reported patient underwent a left hip revision procedure approximately 9 years post-implantation due to alleged pain, elevated metal ion levels, metal poisoning, metallosis, metal debris, metallic-stained tissue, and dehiscence of posterior hip capsule.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Additional information received in patient¿s medical records indicates the right hip revision occurred approximately 9 years post-implantation due to aseptic lymphocyte-dominated vasculitis associated lesion (alval), elevated metal ion levels, pseudotumor, and adverse reaction to metal debris.The revision operative report noted fluid within the joint that appeared reactive to metal debris.The femoral head was removed and replaced and an articulating bearing was implanted.Attempts to obtain additional information have been made; however, no further information is available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.One selex/magnum mod hd 40mm -3 item# s061140 lot# 769000 was returned and evaluated.Upon visual inspection there staining on the od of the device.The inside taper shows some debris.There is no other visible debris.Revision medical records of the patient indicate she underwent a revision surgery to right hip approximately nine years post-implantation due to aseptic lymphocyte-dominated vasculitis associated lesion (alval), elevated metal ion levels, pseudo tumor, and adverse reaction to metal debris.It was noted there was fluid from the joint, which appeared to be reactive from the metal debris, but did not show any signs of infection.The femoral component was removed without complications, and an articulating bearing was implanted.Root cause was unable to be determined.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: ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5858070
• MDR Text Key: 51703308
• Report Number: 0001825034-2016-03010
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: S061140
• Device Lot Number: 769000
• Other Device ID Number: N/A
• 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: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2006
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 76 KG