MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 1 PC SHELL 38MMX54MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems No Code Available (3191); Metal Related Pathology (4530)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: catalog number:1673488, lot number: 162032, brand name: bi-metric hap 12x140 mm, unknown ceramic head.Source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01993.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.

Event Description

It was reported that the patient experienced elevated metal ions approximately 10 years post implantation.Patient has been added to a waiting list for revision surgery, however, no revision has been reported to date.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies 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.

Event Description

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

Manufacturer Narrative

Supplemental report provided as additional information was made available to include explant date (d6b), event update (b5) and patient identifier (a1) as previously reported under mfr #0001825034-2020-01994.

Event Description

It was reported that the patient underwent a revision procedure approximately 12 years after implantation due to raised metal ions and an abnormal mri scan.No additional information is available at the time of this report.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.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 1 PC SHELL 38MMX54MM
• 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: 10066489
• MDR Text Key: 193628055
• Report Number: 0001825034-2020-01994
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 15-105054
• Device Lot Number: 356000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2008
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 70 KG