MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 1 PC SHELL 38MMX56MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Scar Tissue (2060); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 05/27/2015

Event Type  Injury  

Event Description

It was reported patient underwent a left hip revision approximately 10 years post implantation due to pain, difficulty walking, decrease in adls, and increase in metal ions.During the procedure, large fluid was encountered, appeared to be metallosis.Instability of the shell was noted once scar tissue was removed.Also noted, large cavity defects behind the shell, superior bone was poor quality and very thin from lysis.Stem in good position and stable with anteverted neck.The cup and head were exchanged without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products 11-173662- m2a 38mm mod hd std nk- 068320.103206- taperloc por fmrl 12.5x145- 621600.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02265 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

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint was confirmed via medical records and radiographs that were reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A 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.

• Brand Name: M2A 1 PC SHELL 38MMX56MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15543728
• MDR Text Key: 301187476
• Report Number: 0001825034-2022-02264
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 15-105056
• Device Lot Number: 963880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male