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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PROLONG TIBIAL INSERT SZ 3 +0 PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED

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ZIMMER, INC. PROLONG TIBIAL INSERT SZ 3 +0 PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091); Anxiety (2328); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative

Cmp-(b)(4). This report is number 3 of 3 mdrs filed for the same patient (reference 0001822565-2017-04495 / 0001822565-2017-04496 / 0001822565-2017-04497. Concomitant medical devices: palacos bone cement, catalog #: 00-1118-140-01, lot #: 74704314; zimmer ankle tibial base size 3, catalog #: 00450004300, lot number #: 77003690; zimmer talar component blue size 3 left, catalog #: 00450001300, lot number #: 77003664. The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.

 
Event Description

It was reported that a patient underwent a left ankle procedure. On the day of the procedure, mild tarsal/tibial neuritis was noted, and the patient underwent an injection approximately two (2) months post-operatively to treat the issue. This was reported to be not device related, but related to the procedure. Subsequently, mechanical signs of clicking and locking, an abnormal neurovascular assessment without functional limitation or pain, some problems with performing usual daily activities, some mobility issues, and moderate pain or discomfort were noted at six (6) week post-operative follow-up. Six (6) month post-operative follow-up noted: mild swelling, moderate tenderness, some mobility problems and some problems with performing daily usual activities, and severe pain/discomfort. At one (1) year post-operative follow, some mobility problems and problems with performing daily usual activities and severe pain/discomfort were noted. At two (2) year post-operative follow-up, some mobility problems and problems with performing daily usual activities and severe pain/discomfort were noted. Radiographic radiolucency was also noted at two (2) year post-operative follow-up. Attempts have been made to obtain additional information and further information is not available at this time.

 
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Brand NamePROLONG TIBIAL INSERT SZ 3 +0
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED
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 Key6680682
MDR Text Key78813755
Report Number0001822565-2017-04497
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK120906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date01/31/2018
Device MODEL NumberN/A
Device Catalogue Number00450005300
Device LOT Number62267028
OTHER Device ID NumberN/A
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 Received05/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/30/2013
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: 06/30/2017 Patient Sequence Number: 1
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