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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED PROSTHESIS, EXTREMITIES

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ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED PROSTHESIS, EXTREMITIES Back to Search Results
Catalog Number 00840001407
Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/13/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item# 00840004410; lot# 63989902, item# 00840009000; lot# 64093871, item# 00840009400; lot# 64083061. Report source: foreign - event occurred in (b)(6). No product was returned or pictures provided; visual and dimensional evaluations could not be performed. Radiographs were provided and reviewed by a health care professional. Review of the available records identified the following: a hinge-type elbow arthroplasty is present and alignment is anatomic. There is no fracture. There is extensive lucency along the elbow implant extending through the stem and the implant appears radiographically loose. There is faint lucency along the distal aspect of the humeral implant but no lucency along the humeral stem. Osseous proliferation is noted at the distal humerus and proximal ulna and may be associated with impingement. Review of the device history record(s) identified no deviations or anomalies during manufacturing. A definitive root cause cannot be determined. A contributing factor to the loosening is the impingement, however, it could not be confirmed whether the bone growth happened over time or inadequate bone was removed in the initial surgery as op notes and radiographs directly post-op of the initial surgery were 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 that a patient was revised approximately three (3) months post-implantation due to loosening caused by a bony impingement as a result of the original surgery technique. Attempts have been made and no further information has been provided.
 
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Brand NameULNAR COMPONENT PLASMA SPRAYED
Type of DevicePROSTHESIS, EXTREMITIES
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 Key12239619
MDR Text Key263870122
Report Number0001822565-2021-02113
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K181307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00840001407
Device Lot Number64017606
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 Received07/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1
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