MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD+9MM NK NO SKRT; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Scar Tissue (2060); Swelling (2091)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: rd118860- m2a 38mmx60mm cup- 662700 11-104212- mlry-hd lat por fmrl 12x165mm- 419500.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00367, 0001825034 - 2021 - 00368.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.

Event Description

It was reported patient underwent a revision surgery approximately 16 years post implantation due to elevated metal ion levels, pseudocyst, swelling, in-vivo corrosion and scar tissue.During the procedure femoral head was dis-impacted.There was some black material on the trunnion.The trunnion was free of any mechanical defect that was visible.Some impingement noted anteriorly with the trials.Scar tissue was removed from within the anterior capsule as well as some of the areas of bony impingement, a small anterior portion of femur near the trochanter as well as some of the overhanging anterior bone of the acetabulum.The head component was removed and replaced with duel mobility.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on the reported event.

Manufacturer Narrative

Reported event was confirmed via medical records and radiographs reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The review of 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.

Event Description

No additional information on the reported event.

Manufacturer Narrative

H6 component code: mechanical (g04) - head.One m2a 38mm mod hd+9mm nk no skrt item# 11-173665 lot# 271090 was returned and evaluated.Upon visual inspection there is scuffing and a wear line on the od and no visible debris inside of the taper.The additional information does not change the outcome of the previous investigation.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 38MM MOD HD+9MM NK NO SKRT
• 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: 11285951
• MDR Text Key: 230516394
• Report Number: 0001825034-2021-00366
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062997
• 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,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-173665
• Device Lot Number: 271090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2004
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male