MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-M / L TAPER-STEMS-UNK PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Failure of Implant (1924); Local Reaction (2035); Metal Related Pathology (4530)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). It is unknown at this time if the device will be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. 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: 0001822565-2021-00901.

Event Description

It was reported that the patient underwent a revision procedure due to elevated cobalt levels, significant soft tissue extension and metallosis. They have significant findings of cystic degenerative changes inclusive of around the psoas and soft tissue thickening in the capsule and pericapsular tissues. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: HIP-M / L TAPER-STEMS-UNK
• 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: 11590721
• MDR Text Key: 243066646
• Report Number: 0001822565-2021-00900
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Treatment Data

Date Received: 03/30/2021 Patient Sequence Number: 1

Treatment

HIP-OTHER-HEADS-UNK