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

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.

• Brand Name: PROLONG TIBIAL INSERT SZ 3 +0
• Type of Device: PROSTHESIS, 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 Key: 6680682
• MDR Text Key: 78813755
• Report Number: 0001822565-2017-04497
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00450005300
• Device Lot Number: 62267028
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 73