MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM PF CUP 54MM O.D X 48MM I.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Discomfort (2330); Reaction (2414)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04307.

Event Description

It was reported that the patient¿s left hip was revised approximately 8 years post implantation due to pain, discomfort, difficulty walking, loss of range of motion, metallosis and elevated levels of metal ions.The head and cup were removed.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This report is being submitted to relay additional information.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause 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

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

• Brand Name: M2A MAGNUM PF CUP 54MM O.D X 48MM I.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7648442
• MDR Text Key: 112697998
• Report Number: 0001825034-2018-04322
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

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: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 833580
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 10/29/2018; 02/22/2019
• Supplement Dates FDA Received: 11/27/2018; 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 139256 607800 M2A-MAGNUM 42-50 TPR INSRT STD; 14-103209 30040 TAPERLOC MICROP FMRL 17.5MM; 157448 208080 M2A-MAGNUM MOD HD SZ 48MM
• Patient Outcome(s): Hospitalization; Required Intervention