MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 50MM BIOMET CUP PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Migration (4003)

Patient Problems Necrosis (1971); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Ambulation Difficulties (2544)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: biomet, lot#: 105423, cat#443850, na rnglc locking ring sz 23, biomet, lot#11-107003, cat#423860, na r/c ii constrained liner sz 23, stryker stem and head. The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent a right total hip arthroplasty. Subsequently, patient was revised approximately 11 years later due to a loose femoral component. The patient has undergone a second revision approximately 15 years later due to recurrent dislocations. Recently, the patient was revised approximately 1 year later due to pain, protrusio, tissue damage and bone loss. It was noted the case took 200 percent additional time due to complexity of the case. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN 50MM BIOMET CUP
• 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: 10895802
• MDR Text Key: 217999514
• Report Number: 0001825034-2020-04182
• 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: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• 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: 01/12/2021
• 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: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 11/24/2020 Patient Sequence Number: 1