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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. TALAR COMPONENT ORANGE SIZE 4 RIGHT PROSTHESIS, ANKLE SEMI CONSTRAINED

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ZIMMER, INC. TALAR COMPONENT ORANGE SIZE 4 RIGHT PROSTHESIS, ANKLE SEMI CONSTRAINED Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Ecchymosis (1818); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Anxiety (2328); Discomfort (2330); Depression (2361)
Event Date 05/18/2015
Event Type  Injury  
Manufacturer Narrative

(b)(6). This report is number 2 of 3 mdrs filed for the same patient (reference 0001822565 - 2017 - 04416 / 0001822565 - 2017 - 04417 / 0001825034 - 2017 - 04312 ). Concomitant devices zimmer tm ankle tibial base size 4, catalog #: 00450004400, lot # : 77003681, biomet prolong tibial insert sz 4 +0 catalog # : 00450005400, lot # : 62208575. 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 patient underwent right ankle surgery. Subsequently, the patient experienced right ankle pain through two and a half year follow-up visits and symptoms as reported at time intervals as follows: six week follow-up (6 weeks): ecchymosis, moderate tenderness, mild swelling, mild stiffness, unable to perform normal activities, moderate pain, ambulation difficulties. At six (6) month follow-up: some problems with mobility, problems performing normal activities, severe pain. At one (1) year follow-up: mild swelling/tenderness, some mobility/ambulation problems, slight problems with performing usual activities, moderate pain. At two (2) year: mild swelling, problems with mobility/ambulation, severe pain, discomfort. The patient was prescribed narcotics and pain management at some point prior to two and a half year follow-up, however, outcome to the pain is still pending.

 
Manufacturer Narrative

(b)(4). Correction: this report is number 2 of 3 mdrs filed for the same patient (reference 0001822565-2017-04416 / 0001822565-2017-04417 /0001822565-2017-04423).

 
Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. It is noted in primary op-notes that "the trials showed good stability" and "postoperative views were obtained showing good position and alignment of the hardware. " furthermore, it was stated that the device has not failed and is still implanted and working as intended. No known contributing conditions related to the ¿continued ankle pain¿. 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.

 
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Brand NameTALAR COMPONENT ORANGE SIZE 4 RIGHT
Type of DevicePROSTHESIS, ANKLE SEMI CONSTRAINED
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 Key6664707
MDR Text Key78312362
Report Number0001822565-2017-04417
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,Followup,Followup
Report Date 10/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00450002400
Device LOT Number62397421N
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 Received10/06/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/15/2013
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: 06/23/2017 Patient Sequence Number: 1
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