MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 58ODX52ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Malposition of Device (2616); Noise, Audible (3273)

Patient Problems Erosion (1750); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Reaction (2414); Blood Loss (2597)

Event Date 02/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: m2a-magnum mod hd sz 52mm, pn 157452, ln 101240, m2a-magnum 52-60mm tpr insrt-3, pn 139266, ln 068770, taperloc por fmrl 15x150, pn 103208, ln 301550.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00104, 0001825034-2020-00105, 0001825034-2020-00106.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient became infected and had the hip irrigated and debrided on an unknown date.The patient received antibiotics for 6 weeks.Then the patient was revised approximately one year later.Findings at the time of the revision were: stem was well positioned and fixed, acetabular shell was fixed, steep and overly and anteverted, head adapter was cold welded to the stem trunnion so large head was first separated from the adaptor so the taper adaptor can be removed.The articular surface of the head shows severe corrosion as well as high cobalt levels.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Primary right tha was performed.Patient subsequently developed elevated metal ions and noise.Attempted revision procedure; however, surgical procedure was aborted and surgical site was irrigated and closed.Patient experienced a superficial infection.Approximately 3 months later, patient underwent revision procedure due to elevated metal ion levels, metallosis, corrosion and malposition of the acetabular component.During the procedure, estimated blood loss was 1600 ml.Attempts were made to obtain additional information; however, none was available.

Event Description

It was reported that patient developed elevated metal ion levels and noise and underwent a right hip revision approximately 8 years post implantation.During the procedure, the surgeon was unable to disengage the head so the procedure was aborted and the surgical site was irrigated and closed.Approximately 1 week later, the patient developed fever and superficial surgical site infection.The surgical site was irrigated and debrided.Approximately 2 months later, the patient returned for another attempt at revising the devices after the wound infection had cleared.Upon removing the head component, corrosion was found along with malpositioning of the cup.Bone erosion was noted behind the cup and repaired with a bone graft.Attempts have been made and additional information is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed by review of medical records noting elevated metal ion levels, metallosis staining and synovium.First attempted procedure was aborted due to inability to remove the head.Infection developed at the surgical site approximately 1 week later where i&d was performed.A second attempted procedure was completed about 2 months later, osteolytic area found behind the shell and a bone graft placed.Corrosion debris found on the trunnion of the stem.Dhr was reviewed and no discrepancies were found.The root cause is 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: M2A-MAGNUM PF CUP 58ODX52ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9569833
• MDR Text Key: 174533126
• Report Number: 0001825034-2020-00107
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: US157858
• Device Lot Number: 722540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 113