MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 64ODX58ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problems Pain (1994); Local Reaction (2035); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 03/02/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent hip revision an unknown number of years post implantation due to metallosis.During the procedure, the head and taper components were removed.Patient was converted to active articulation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4)/ concomitant products: item #: unknown, 58mm m2a magnum head , lot #: 832890; item #: unknown , unknown stem , lot #: unknown; item #: unknown , unk m2a taper adapter , lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00507.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Radiographs identified the following: left hip arthroplasty is anatomically aligned.There is no fracture or dislocation.Overall fit and alignment are maintained.Bone quality is osteopenic.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

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.D10: cat# 192413 lot# 784560 echo por fmrl red nc 13x145mm.Cat# 139274 lot# 661910 m2a-magnum 52-60mm tpr insr +9.Cat# 139274 lot# 661910 tapper adapter.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: benign-appearing bloody fluid sent for gram stain, culture and sensitivity, and cell count.Once implants constructed, copiously irrigated with irrisept and saine, debrided, no more metalosis remained after debridement.The additional information does not change the outcome of the previous investigation.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.

Event Description

It was reported that the patient underwent an initial left hip arthroplasty.Subsequently, the patient was revised approximately 13 years later due to "metallosis".It was reported that the joint was irrigated with copious amounts of irrisept and saline to ensure no "metallosis" remained.No intraoperative complications were reported.

• Brand Name: M2A-MAGNUM PF CUP 64ODX58ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13758111
• MDR Text Key: 287128926
• Report Number: 0001825034-2022-00508
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: US157864
• Device Lot Number: 999520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 04/05/2022; 08/03/2023
• Supplement Dates FDA Received: 04/07/2022; 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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: 157458 M2A 58MM HEAD 832890.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female