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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 32MM +3 MAXROM LNR SZ22 HIP PROSTHESIS

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ZIMMER BIOMET, INC. E-POLY 32MM +3 MAXROM LNR SZ22 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem No Code Available (3191)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 106022, locking ring, lot # 666530. Item # 16-104146, cup, lot # 640690. Item # xl-108222, liner, lot # 696150. Item # 103531, bone screw, lot # 063030. Item # 103533, bone screw, lot # 064250. Item # 163667, femoral head, lot # 824420. Item # 51-108080, femoral stem, lot # 3275307. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03932, 0001825034-2018-03934, 0001825034-2018-03935.
 
Event Description
It was reported that during an initial hip procedure, a cup was implanted. The surgeon was unable to get multiple liners to seat in the implanted cup. An attempt was made using an alternate locking ring, which was also unsuccessful. All acetabular components were removed and replaced with competitor product. The device malfunction caused a surgical delay of one hour. Attempts have been made, and no further information has been provided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event. The initial report was forwarded in error and should be voided.
 
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Brand NameE-POLY 32MM +3 MAXROM LNR SZ22
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7592880
MDR Text Key110809810
Report Number0001825034-2018-03933
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 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/19/2022
Device Model NumberN/A
Device Catalogue NumberEP-108222
Device Lot Number274340
Other Device ID Number(01) 0 0880304 46908 2
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/12/2018 Patient Sequence Number: 1
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