MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM 42-50M TPR INSRT +6; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035); Scar Tissue (2060)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk- +6mm head adapter-unk.Unk- size 6 taper lock standard offset femoral stem-unk.Unk-unk magnum head w/size 42 +6head adaptor-unk.Unk-unk 52mm magnum cup-unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020 -01914.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product location unknown.

Event Description

It was reported the patient underwent a left hip revision approximately 11 years post implantation due to positive mri findings and elevated metal ions.During the procedure a tannish loose tissue debris was identified consistent with metal reaction.Minimal corrosion found.The femoral head was replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d6; g4; g5; h2; h3; h4; h6.Reported event was confirmed via medical records and radiographs reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) positive mri findings and mild elevation consistent with metal failure, released adhesions/scar tissue.Released posterior hip pseudocapsule.Tannish loose tissue debris was identified consistent w/metal reaction, frozen sections sent for review were not suspicious.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.One m2a-magnum mod hd sz 46mm with the insert was returned.Upon visual inspection the taper had some scuffing but no visible debris.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

No additional information on the reported event.

• Brand Name: M2A MAGNUM 42-50M TPR INSRT +6
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10024120
• MDR Text Key: 189911067
• Report Number: 0001825034-2020-01886
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 139259
• Device Lot Number: 631060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention