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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MODULAR HEAD PROSTHESIS HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MODULAR HEAD PROSTHESIS HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Local Reaction (2035); Swelling (2091); Tissue Damage (2104); Reaction (2414); Swelling/ Edema (4577)
Event Date 01/23/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: m2a-magnum pf cup, # item us157852, lot 768350. Taperloc por fmrl, # item 103200, lot 005640. M2a-magnum tpr inserter, # item 139254, lot unk. Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-09547. It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a revision approximately eight years post initial surgery due to elevated metal ions. During the revision surgery, the surgeon noted a large murky fluid collection and stained synovial tissue in the posterior capsule as well as clear trunnion corrosion. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies relevant to the reported event were found. 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
No new information received.
 
Manufacturer Narrative
Concomitant medical products: m2a-magnum tpr inserter # item 139254 lot 615530. The event was confirmed with medical records received. Ebl 200ml, frozen sections negative for acute inflammation, patient presented with pain and swelling with elevated metal ions, murky fluid encountered, but no pseudocapsule, trunnion corrosion noted without damage to the trunnion, femoral and acetabular components well-fixed. Dhr was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to 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.
 
Event Description
No further event information available at the time of this report.
 
Event Description
No additional information on the reported event.
 
Manufacturer Narrative
Final: this follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. One m2a-magnum mod hd sz 46mm was returned and evaluated. Upon visual inspection there was scuffing on the outside diameter and visible debris inside of the taper. A review of the device history records identified no deviations or anomalies during manufacturing. Root cause of the event could not 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.
 
Event Description
It was reported that the patient underwent a revision approximately eight years post initial surgery due to pain, swelling, and elevated metal ions. During the revision surgery, the surgeon noted a large murky fluid collection and stained synovial tissue in the posterior capsule as well as clear trunnion corrosion and tissue damage.
 
Manufacturer Narrative
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.
 
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Brand NameM2A-MAGNUM MODULAR HEAD
Type of DevicePROSTHESIS HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7951165
MDR Text Key123208433
Report Number0001825034-2018-09546
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PK833175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
Device Model NumberN/A
Device Catalogue Number157446
Device Lot Number217340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/10/2018 Patient Sequence Number: 1
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