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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH PROSTHESIS, KNEE

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ZIMMER, INC. STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2016
Event Type  malfunction  
Manufacturer Narrative
Photographs of complaint sample were evaluated and the reported event was confirmed. The product is implanted and reported plastic bag was thrown away. So from the evaluation of returned photos, it was determined that, the holes are present on the poly bag. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that there were holes in the inner bag. The procedure was completed with the implant as the sterile box was intact.
 
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Brand NameSTEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6224744
MDR Text Key249038288
Report Number0001822565-2017-00064
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PK133737
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42557000114
Device Lot Number63431028
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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