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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 36MM +3 MAXROM LNR SZ23 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. E-POLY 36MM +3 MAXROM LNR SZ23 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2022
Event Type  Injury  
Event Description
It was reported patient underwent a right hip revision due to implant fracture. The lip of the liner cracked and had to be removed. Locking mechanism was damaged so entire cup was removed and replaced. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Patient in her 50s. Concomitant products: 650-1057- cer bioloxd option hd 36mm- 2964345; 650-1064- cer option type 1 tpr sleve -6- 2962119; 13-104052- m/h radial solid/apx shl 52mm- 604150. Customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Requested but not returned by hospital.
 
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Brand NameE-POLY 36MM +3 MAXROM LNR SZ23
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13385412
MDR Text Key284628289
Report Number0001825034-2022-00185
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberEP-108223
Device Lot Number639280
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 01/28/2022 Patient Sequence Number: 1
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