MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12/14 M2A-38 MOD HD-3.5MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Scratched Material (3020)

Patient Problem Host-Tissue Reaction (1297)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:15-105050 lot number: 049820 brand name: m2a 38 cup, catalog number: 650-0971 lot number: 1397574 brand name: taperloc stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02044.Investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to metallosis approximately 7 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

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.

• Brand Name: 12/14 M2A-38 MOD HD-3.5MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8575817
• MDR Text Key: 143934309
• Report Number: 0001825034-2019-02043
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 14-380351
• Device Lot Number: 672500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 05/22/2019
• 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