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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Cyst(s) (1800); Necrosis (1971); Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530)
Event Date 02/20/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant products: unknown m/l taper stem; unknown cup; femoral head cat# 00-8018-036-02 lot# 60774028; unknown kinectiv neck. Reported event was confirmed by review of medical records. Medical records were provided and reviewed by a health care professional. Review of the available records identified the following: the patient underwent an initial right hip arthroplasty on (b)(6) 2008 due to degenerative arthritis. The patient was revised on (b)(6) 2019 due to failed hip arthroplasty. Blood work : (b)(6) 2017 ¿ chromium <0. 5 mcg/l, cobalt 2. 9 mcg/l h range <
=
1. 8 mcg/l. (b)(6) 2018 ¿ chromium 0. 5 mcg/l, cobalt 5. 8 mcg/l h range <
=
1. 8 mcg/l. The patient had pain and persistent instability of the hip. Mri revealed massive pseudotumor throughout the hindquarter and proximal femur. The hip capsule was pierced decompressing a massive fluid-particulate effusion and cyst, which seemed to deflate the prominent bulging cyst over the greater trochanter. A massive pseudotumor was debrided from the joint. The entire greater trochanter was "bald". There were no soft tissue attachments of the abductors or short external rotators to the greater trochanter. Significant corrosion was observed in the head's taper. There were various circular erosion patterns of the trunnion of the neck but no gouges or deformity. Significant amount of osteolysis of the acetabulum involving the entire posterior column and the wall exposing the posterior half of the metal shell. The shell and stem were well fixed. The head, liner, and locking ring were replaced with new zimmer biomet products. No other findings/complications related to the reported event were noted. Photographs of the explanted products were provided. Visual evaluation identified the following: the products were covered in biodebris. There was discoloration on the liner and on the surface of the head's taper. No further evaluation is possible with the images provided. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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
It was reported through patient's medical records that the patient underwent a right hip revision approximately 11 years post implantation due to elevated metal ion levels, synovitis, pain, pseudotumor, metallosis, bone erosion, instability, cyst, necrosis, scar tissue, in-vivo corrosion, and osteolysis.
 
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Brand NameUNKNOWN LINER
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 Key11821301
MDR Text Key250799500
Report Number0001822565-2021-01328
Device Sequence Number1
Product Code KWA
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 consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
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 Received05/12/2021
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 Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/13/2021 Patient Sequence Number: 1
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