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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION

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ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Model Number 630-254
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Headache (1880); Pain (1994); Swelling (2091); Chills (2191); Joint Swelling (2356); Malaise (2359); Reaction (2414); No Code Available (3191)
Event Date 12/02/2014
Event Type  Injury  
Event Description
On (b)(6) 2014 caller had a swollen knee and was diagnosed with a knee infection. On (b)(6) 2014 her knee gave up on her and was told she had a torn acl, mcl and meniscus. She had a 3 session therapy of orthovisc injection from (b)(6). Right after the first injection, she started to experience adverse reaction of knee pain, swelling and flu like symptoms, fatigue, chills and headache. She continues to experience pain and revisited her doctor in (b)(6) 2015 and was given a cortisone shot. An mri was done on (b)(6) 2015 and was informed that she needs a debridement. After the debridement, another session of orthovisc injection was given from (b)(6) 2014 but these did not stop the pain. She was then advised to get a knee replacement. She contact a specialist for a second opinion and was given the care needed and the pain subsided with no further injections or surgery. Through research on the web, she learned about orthovisc injection and the adverse reaction on the fda website which the first doctor failed to share with her. Fda should take this device off the market.
 
Manufacturer Narrative
Additional information was received from the patient on june 07, 2016 : felt like she had the flu, body aches (body hurt). Symptoms lasted 72 hours. This occurred after both the 2014 and 2015 set of orthovisc shots. She was later diagnosed with back issues and feels the cause is orthovisc.
 
Event Description
On (b)(6) 2014 caller had a swollen knee and was diagnosed with a knee infection. On (b)(6) 2014 her knee gave up on her and was told she had a torn acl, mcl and meniscus. She had a 3 session therapy of orthovisc injection from (b)(6). Right after the first injection she started to experience adverse reaction of knee pain, swelling and flu like symptoms, fatigue, chills and headache. She continues to experience pain and revisited her doctor in (b)(6) 2015 and was given a cortisone shot. An mri was done on (b)(6) 2015 and was informed that she needs a debridement. After the debridement another session of orthovisc injection was given from (b)(6) 2014 but these did not stop the pain. She was then advised to get a knee replacement. She contact a specialist for a second opinion and was given the care needed and the pain subsided with no further injections or surgery. Through research on the web she learned about orthovisc injection and the adverse reaction on the fda website which the first doctor failed to share with her. Fda should take this device off the market.
 
Manufacturer Narrative
Additional information was received from the patient on june 07, 2016: felt like she had the flu, body aches (body hurt). Symptoms lasted 72 hours. This occurred after both the 2014 and 2015 set of orthovisc shots. She was later diagnosed with back issues and feels the cause is orthovisc. Her knee is finally getting better since physical therapy. Additional information was received from the patient on august 02, 2016: she still has pain, but nothing like it was in march. Additional information was received from the patient on august 05, 2016: she has improved. The lot # 's of the first 3 injections in 2014 were all the same, n140020a. The 3 injections in 2015 were lots n150047a, n150048d and n150053a. Lot # n140020a was manufactured on 26mar2014 and expires on 31mar2016. Lot # n150047a was manufactured on 08jul2015 and expires on 31jul2017. Lot # n150048d was manufactured on 13jul2015 and expires on 31jul2017. Lot # n150053a was manufactured on 26aug2015 and expires on 31aug2017.
 
Event Description
On (b)(6) 2014 caller had a swollen knee and was diagnosed with a knee infection. On (b)(6) 2014 her knee gave up on her and was told she had a torn acl, mcl and meniscus. She had a 3 session therapy of orthovisc injection from (b)(6). Right after the first injection she started to experience adverse reaction of knee pain, swelling and flu like symptoms, fatigue, chills and headache. She continues to experience pain and revisited her doctor in (b)(6) 2015 and was given a cortisone shot. An mri was done on (b)(6) 2015 and was informed that she needs a debridement. After the debridement another session of orthovisc injection was given from (b)(6) 2014 but these did not stop the pain. She was then advised to get a knee replacement. She contact a specialist for a second opinion and was given the care needed and the pain subsided with no further injections or surgery. Through research on the web she learned about orthovisc injection and the adverse reaction on the fda website which the first doctor failed to share with her. Fda should take this device off the market.
 
Manufacturer Narrative
Additional information was received from the patient on june 07, 2016 : felt like she had the flu, body aches (body hurt). Symptoms lasted 72 hours. This occurred after both the 2014 and 2015 set of orthovisc shots. She was later diagnosed with back issues and feels the cause is orthovisc. Her knee is finally getting better since physical therapy. Additional information was received from the patient on august 02, 2016: she still has pain, but nothing like it was in march. Additional information was received from the patient on august 05, 2016: she has improved. The lot # 's of the first 3 injections in 2014 were all the same, n140020a. The 3 injections in 2015 were lots n150047a, n150048d and n150053a. Lot # n140020a was manufactured on 26mar2014 and expires on 31mar2016. Lot # n150047a was manufactured on 08jul2015 and expires on 31jul2017. Lot # n150048d was manufactured on 13jul2015 and expires on 31jul2017. Lot # n150053a was manufactured on 26aug2015 and expires on 31aug2017. Additional information as of november 10, 2016: the product associated with the reported event was not returned and therefore could not be tested or analyzed. However, anika conducted an investigation on each lot of product manufactured, based on the lot numbers that were provided by the customer. A thorough review of materials, manufacturing, quality control testing and product releases were evaluated for each lot. There were no activities that would raise concern regarding the safety and effectiveness of orthovisc lots n140020a, n150047a, n150048d or n150053a. Complaint history was reviewed to determine if there were any similar complaints to these reported batches. There have been no complaints reported similar to the symptoms reported in (b)(4).
 
Event Description
On (b)(6) 2014 caller had a swollen knee and was diagnosed with a knee infection. On (b)(6) 2014 her knee gave up on her and was told she had a torn acl, mcl and meniscus. She had a 3 session therapy of orthovisc injection from (b)(6). Right after the first injection she started to experience adverse reaction of knee pain, swelling and flu like symptoms, fatigue, chills and headache. She continues to experience pain and revisited her doctor in (b)(6) 2015 and was given a cortisone shot. An mri was done on (b)(6) 2015 and was informed that she needs a debridement. After the debridement another session of orthovisc injection was given from (b)(6) 2014 but these did not stop the pain. She was then advised to get a knee replacement. She contact a specialist for a second opinion and was given the care needed and the pain subsided with no further injections or surgery. Through research on the web she learned about orthovisc injection and the adverse reaction on the fda website which the first doctor failed to share with her. Fda should take this device off the market.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
32 wiggins avenue
bedford MA 01730
Manufacturer (Section G)
ANIKA THERAPEUTICS, INC.
32 wiggins avenue
bedford MA 01730
Manufacturer Contact
hannah coggins
32 wiggins avenue
bedford, MA 01730
7814579000
MDR Report Key5701702
MDR Text Key46666308
Report Number3007093114-2016-00003
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup,Followup,Followup
Report Date 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number630-254
Device Lot NumberSEE ADDITIONAL NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/06/2016 Patient Sequence Number: 1
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