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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X250MM INTLKNG DIST PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS 15X250MM INTLKNG DIST PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Code Available (3191)
Event Date 06/28/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03090.
 
Event Description
It was reported that arcos interlocking stem was used and secured with screw. Proximal cone body prepared for and then trialed on the stem. Cone body got stuck on the stem. The staff was unable to remove it and had to remove interlocking stem and replace with a larger one. There was a delay of 60 min. 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
Udi# (b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Review of the device history record for the distal stem identified no deviations or anomalies would contribute to reported event. 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.
 
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Brand NameARCOS 15X250MM INTLKNG DIST
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8817738
MDR Text Key151925519
Report Number0001825034-2019-03089
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K100469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number11-301915
Device Lot Number084370
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/23/2019 Patient Sequence Number: 1
Treatment
UNKNOWN ARCOS CONE BODY; ZIMMER SCREW CAT#47248303050 LOT#63733805; UNKNOWN ARCOS CONE BODY; ZIMMER SCREW CAT#47248303050 LOT#63733805
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