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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M2A LINER PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN M2A LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Event Date 06/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). No product was returned or pictures provided; visual and dimensional evaluations could not be performed. Part and lot identification are necessary for review of device history records, neither were provided. Medical records/radiographs were provided and reviewed by a health care professional. A review of the available records identified findings of the reported issues. The op records indicate lysis, elevated chromium levels, tendon tear, pain, limping, metallosis, tumor, and bone loss as reported. No complications were noted in the op record. A definitive root cause cannot be determined. 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.   multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02175, 0001825034 - 2021 - 02174.
 
Event Description
It was reported a patient underwent an initial right total hip arthroplasty performed on an unknown date. Subsequently, the patient underwent revision of all components approximately ten (10) years post implantation due to pain, tissue damage, and metallosis. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN M2A 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 Key12703817
MDR Text Key278561646
Report Number0001825034-2021-02933
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 company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
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 Received10/21/2021
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: 10/27/2021 Patient Sequence Number: 1
Treatment
UNKNOWN M2A STEM
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