MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM M2A HI CARBON HD +3MM NK; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Host-Tissue Reaction (1297)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 10-104052 ¿ m2a taper cup ¿ 254250; 15-105044 ¿ m2a taper mom liner ¿ 409130; unknown stem - unknown part and lot.Report source : (b)(6).This product is not cleared for distribution in the u.S.However, this report is being submitted as a similar device is cleared for distribution under 510k number k042037.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the surgeon did not approve of the return.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: 0001825034-2019-03465, 0001825034-2019-03466.

Event Description

It was reported that patient underwent a revision surgery approximately 10 years post implantation due to suspicion of pseudotumor.Attempts have been made and 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.Dhr 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 additional event information at this time.

• Brand Name: 32MM M2A HI CARBON HD +3MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8873536
• MDR Text Key: 153659354
• Report Number: 0001825034-2019-03467
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-163689
• Device Lot Number: 404460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention