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

Catalog Number US157858

Device Problems Material Erosion (1214); Failure to Osseointegrate (1863); Loss of Osseointegration (2408)

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Blood Loss (2597)

Event Date 02/18/2019

Event Type  Injury  

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.Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: part # 139270 / taper / lot # 799680, part # 157452 / m2a head / lot # 139710, part # 12-103208 /stem/ lot # 266410.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01401, 0001825034 -2020 -01402, 0001825034 -2020 -01403.

Event Description

It was reported that patient underwent hip revision surgery 13 years post implantation due to pain and elevated metal ion levels.During the revision, the acetabular shell was found to be grossly loose with bone erosion posterior to the cup which has limited ingrowth.After additional scar tissue was removed, the stem remained intact but all other components were revised without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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 further event information available at the time of this report.

• Brand Name: M2A-MAGNUM PF CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9904371
• MDR Text Key: 187363629
• Report Number: 0001825034-2020-01400
• 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: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2016
• Device Catalogue Number: US157858
• Device Lot Number: 138930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention