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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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: 0001822565 - 2021 - 01166.
 
Event Description
It was reported the polyethylene liner would not seat in the acetabular shell. Another liner was used to complete the procedure. There was no patient injury as a result of the malfunction. No additional information.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameLINER 28 MM I.D.
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key11737126
MDR Text Key247684460
Report Number0002648920-2021-00101
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K833991
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 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00500104728
Device Lot Number64107751
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
Treatment
CAT# 00500104700 SHELL 47 MM LOT#64731146; CAT#00500104800SHELL 48MM LOT#64146944; CAT#802202802 ZB 12/14 COCR HD LOT#3038825; CAT#802202802ZB 12/14COCR HD28MMLOT#64822650; CAT#00500104800,SHELL 48.MM LOT#64146944; CAT#802202802,ZB 12/14.COCR HD28MMLOT#64822650
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