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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 22X190MM SPL TPR DIST; PROSTHETIC, HIP
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ZIMMER BIOMET, INC. ARCOS 22X190MM SPL TPR DIST; PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Unequal Limb Length (4534)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01399.
 
Event Description
It was reported by pmi group that a custom hip needed for revision on unknown date.The surgeon wants to add an adapter to the current hip implant to correct the leg length discrepancy.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Upon reassessment of the reported event, the taper was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, the taper was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
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Brand Name
ARCOS 22X190MM SPL TPR DIST
Type of Device
PROSTHETIC, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11783956
MDR Text Key249262066
Report Number0001825034-2021-01398
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number11-300922
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/22/2021
Initial Date FDA Received05/06/2021
Supplement Dates Manufacturer Received05/10/2021
08/31/2021
Supplement Dates FDA Received06/01/2021
09/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
ITEM# 11-301334 ARCOS CON SZ D HI 70MM LOT# UNK; UNKNOWN +3 CERAMIC HEAD; UNKNOWN 44 NEUTRAL LINER; UNKNOWN G7 MULTI HOLE SHELL; ITEM# 11-301334 ARCOS CON SZ D HI 70MM LOT# UNK; UNKNOWN +3 CERAMIC HEAD; UNKNOWN 44 NEUTRAL LINER; UNKNOWN G7 MULTI HOLE SHELL
Patient Outcome(s) Hospitalization; Required Intervention;
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