MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD -6MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Local Reaction (2035); Swelling (2091); No Code Available (3191)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: (b)(6) 2003.Concomitant medical devices: item #: unknown, unknown stem, lot #: unknown; item #: unknown, unknown cup, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product was returned to the customer and the location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02696 cup, 0001825034 - 2020 - 02697 stem.

Event Description

It was reported patient underwent left hip revision approximately seventeen years post implantation due to a mass.During the procedure head, cup and stem components were removed and replaced with a dual mobility system.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records indicate that the patient underwent an initial left tha due to osteoarthritis; no intraoperative complications were noted.Patient was revised due to an identified mass.Patient developed swelling and large soft tissue tumor creating vascular compromise and venous thrombosis removed 3 months prior by vascular surgery team.Stem and cup were well fixed; elected not to revise however osteolytic regression of supportive bone of both implants.No abnormal findings of trunnion and articular surface.Pseudocapsule noted posteriorly, dense fibrous tissue excised and sent to pathology.Head was explanted and replaced with dual articulation.No intraoperative complications noted.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 patient underwent left hip revision approximately seventeen years post implantation due to a psuedotumor, swelling, altr, dvt, and osteolysis.During the procedure head, cup and stem components were removed and replaced with a dual mobility system.No additional information is available.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D11: taperloc femoral porous coated 103201 lot# 931140.M2a 38mm x48 rd118848 lot#982610.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 report 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and complaint sample evaluation.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.An m2a 38mm mod hd -6mm nk, part # 11-173660 from lot 521480, was returned and evaluated against the complaint.Visual inspection found dings on the rim of the head.Dark debris is present inside the taper.The outer radius is scratched and covered in a dried light colored film.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 report 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 38MM MOD HD -6MM NK
• 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: 10257388
• MDR Text Key: 198320625
• Report Number: 0001825034-2020-02695
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-173660
• Device Lot Number: 521480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 09/04/2020; 09/14/2020; 10/12/2020; 11/05/2020; 03/28/2022
• Supplement Dates FDA Received: 09/09/2020; 09/28/2020; 10/22/2020; 11/09/2020; 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female