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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN CR-FLEX (GSF) FEMORAL COMPONENT POROUS PROSTHESIS, KNEE

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ZIMMER, INC. NEXGEN CR-FLEX (GSF) FEMORAL COMPONENT POROUS PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Unstable (1667)
Patient Problems Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544)
Event Date 07/13/2016
Event Type  Injury  
Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. The following could not be completed with the limited information provided. Age/date of birth - ni, weight - ni, product code - ni, expiration date - ni, establishment name - ni, device manufacture date - ni. This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified. This report is 1 of 2 for the same patient (reference 1822565-2017-00810 / 00811 ).

 
Event Description

It is reported that the patient was revised due to pain, laxity, and loosening approximately 15 months after implantation. Patient began reporting pain 6 weeks post-implantation and feels the implant was not properly sized. Patient also stated there was scar tissue formation in the operative knee. This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Concomitant medical products¿ trabecular metal monoblock tibia catalog 00588604310 lot 61785348. Customer has not indicated that the product will 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 report: 3005751028-2017-00047.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies relevant to the reported event 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. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. 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 NameNEXGEN CR-FLEX (GSF) FEMORAL COMPONENT POROUS
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 Key6326859
MDR Text Key67277702
Report Number0001822565-2017-00810
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK072619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00575201402
Device LOT Number62223977
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2012
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

Patient TREATMENT DATA
Date Received: 02/13/2017 Patient Sequence Number: 1
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