MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MODULAR HEAD; PROSTHESIS HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Local Reaction (2035); Swelling (2091); Tissue Damage (2104); Reaction (2414); Swelling/ Edema (4577)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: m2a-magnum pf cup, # item us157852, lot 768350.Taperloc por fmrl, # item 103200, lot 005640.M2a-magnum tpr inserter, # item 139254, lot unk.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-09547.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision approximately eight years post initial surgery due to elevated metal ions.During the revision surgery, the surgeon noted a large murky fluid collection and stained synovial tissue in the posterior capsule as well as clear trunnion corrosion.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 new information received.

Manufacturer Narrative

Concomitant medical products: m2a-magnum tpr inserter # item 139254 lot 615530.The event was confirmed with medical records received.Ebl 200ml, frozen sections negative for acute inflammation, patient presented with pain and swelling with elevated metal ions, murky fluid encountered, but no pseudocapsule, trunnion corrosion noted without damage to the trunnion, femoral and acetabular components well-fixed.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

Event Description

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

Event Description

No additional information on the reported event.

Manufacturer Narrative

Final: this follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.One m2a-magnum mod hd sz 46mm was returned and evaluated.Upon visual inspection there was scuffing on the outside diameter and visible debris inside of the taper.A review of the device history records identified no deviations or anomalies during manufacturing.Root cause of the event could not 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.

Event Description

It was reported that the patient underwent a revision approximately eight years post initial surgery due to pain, swelling, and elevated metal ions.During the revision surgery, the surgeon noted a large murky fluid collection and stained synovial tissue in the posterior capsule as well as clear trunnion corrosion and tissue damage.

Manufacturer Narrative

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 MODULAR HEAD
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7951165
• MDR Text Key: 123208433
• Report Number: 0001825034-2018-09546
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 217340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention