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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN 50MM BIOMET CUP PROSTHESIS, HIP Back to Search Results
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.
 
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Brand NameUNKNOWN 50MM BIOMET CUP
Type of DevicePROSTHESIS, 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 Key10895802
MDR Text Key217999514
Report Number0001825034-2020-04182
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
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 Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/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 Received01/12/2021
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 NumberN/A

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