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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 26 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS; PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. LINER 26 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2016
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.
 
Event Description
It was reported that the device was found disassembled at the time of opening.The surgery was finished with alternate device.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was not confirmed.The locking ring was positioned inside the liner as designed.Neither the liner or locking ring shows signs of damage or wear that would indicate an attempt to implant was made.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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 Name
LINER 26 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key6139639
MDR Text Key61292378
Report Number0002648920-2016-03317
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PK833991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/31/2023
Device Model NumberN/A
Device Catalogue Number00500104226
Device Lot Number63134043
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2017
Initial Date Manufacturer Received 11/01/2016
Initial Date FDA Received12/01/2016
Supplement Dates Manufacturer Received09/13/2018
Supplement Dates FDA Received09/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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