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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ24 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ24 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Information (3190)
Event Date 03/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr's were reported for this event. Please also see associated events: 0001825034 - 2018 - 02364, 0001825034 - 2018 - 02366, 0001825034 - 2018 - 02367. Concomitant medical products: pt-106056 regen/rnglc+ multi 56mm sz 24 lot 752890, ep-108524 e-poly 40mm +3 hiwall lnr sz24 lot 168940, 16-116054 rnglc+ ltd hole shell sz54 lot 720230. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
 
Event Description
It was reported the acetabular liner would not lock into the acetabular cup, resulting in a delay of 1-2 hours. Attempts have been made and no further information has been made available.
 
Manufacturer Narrative
The follow up report is submitted to relay additional information received: udi: (b)(4). The liner was returned but it is unknown which one of the two was returned. Complaint sample was evaluated and the reported event was confirmed. Both shells and one liner were returned and evaluated. Upon visual inspection the liner was damage around the scallops. Both shells show no visible damages. Dimensional analysis on the shells were conforming to print specifications. Dimensional analysis on the liner cannot be performed due to its impaction and resulting damage. The other liner was not returned. The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event. A definite root cause cannot be determined with information available. 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 NameE-POLY 40MM +3 HIWALL LNR SZ24
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7416626
MDR Text Key105143841
Report Number0001825034-2018-02365
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
PMA/PMN Number
PK090103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/15/2022
Device Model NumberN/A
Device Catalogue NumberEP-108524
Device Lot Number925850
Other Device ID Number(01) EP-108524
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
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