MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM M2A HI CARBON HD +6MM NK; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Concomitant medical products: 10-104052-m2a-t m/h rad 2hl shl 41/52mm-705650; 15-105044- m2a tpr hi carbon 41/32mm lnr- 256070; unknown- unknown bi-metric stem- unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01421.Customer has indicated that the product will not be returned to zimmer biomet for investigation, surgeon didn't approve for return.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 13 years post implantation due to metallosis and pain.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 component code: mechanical (g04) - head.Visual examination of the provided pictures identified the articulation surface of the head and shell show damage and scuffing.Review of the device history record(s) 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.

• Brand Name: 32MM M2A HI CARBON HD +6MM NK
• 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: 14744474
• MDR Text Key: 294938128
• Report Number: 0001825034-2022-01420
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003363
• 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
• Report Date: 06/30/2022

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 Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 11-163690
• Device Lot Number: 343310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• 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 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention