MAUDE Adverse Event Report: ZIMMER BIOMET, INC. METASUL INSERT APR 61/28; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Host-Tissue Reaction (1297); Metal Related Pathology (4530)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 19.28.07 2016910 metasul hd 28mm l 12/14; unknown stem; unknown cup.Foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 04240.

Event Description

It was reported patient underwent initial hip arthroplasty.Subsequently; the patient was revised approximately 10 months post implantation due to a pseudotumor.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h4; h6 reported event was unable to be confirmed due to limited information received from the customer.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 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: METASUL INSERT APR 61/28
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11087336
• MDR Text Key: 224075888
• Report Number: 0001822565-2020-04239
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K033634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2021

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 Model Number: N/A
• Device Catalogue Number: 437228061
• Device Lot Number: 1366865
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 02/10/2021; 04/14/2021
• Supplement Dates FDA Received: 02/23/2021; 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention