MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-38 CUP NON FLARED SZ 70MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Tissue Damage (2104); Joint Dislocation (2374); Osteolysis (2377); Reaction (2414); Ambulation Difficulties (2544)

Event Date 05/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of operative notes.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

It was reported that patient underwent a left hip revision approximately 10 year post implantation due to pain, metallosis, elevated metal ion levels, osteolysis, pseudotumor, dislocation, periprosthetic acetabular fracture, tissue damage and lack of mobility.

• Brand Name: M2A-38 CUP NON FLARED SZ 70MM
• 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: 8189849
• MDR Text Key: 131165919
• Report Number: 0001825034-2018-11528
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 15-106070
• Device Lot Number: 912330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2005
• 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
• Patient Outcome(s): Hospitalization; Required Intervention