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

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)

Patient Problem Fall (1848)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Event description as received on (b)(6) 2016: "faxed paper work from the pap group stating it started on the right side first injected 2cc of orthovisc batch number n150087a, 01/18 expiration with 2cc of 1% lidocaine without epinephrine or preservative and 40 mg of preservative free kenalog.I prepped with alcohol and chloraprep.I injected without difficulty.I did get verbal consent and the patient identified the right side as the correct side.I then went to the left side third injection 2cc of orthovisc batch number n150087a, 01/18 expiration and with 2cc of 1% lidocaine without epinephrine or preservatives and 40 mg of preservative free kenalog.I prepped with alcohol and chloraprep.I injected with following ethyl chloride anesthesia into the glenohumeral joint without difficulty.This is the third injection in her left shoulder so we did two injections one in the right one in the left both third injections.She tolerated the injections sent her on the way talked about surgery.She did fall.She got x-rays at (b)(6) two views right shoulder.She has pretty severe medialization multiple vascular clips consisting with lymph node dissection and a small chip medially inferior glenoid.I do believe that her humerous is impinging on her glenoid inferiorly because she has a medial wear and probably cracked that.Otherwise, i did not see any fracture that were obvious my thoughts even doing a shoulder replacement on her.It is going to be a challenge because she has such medialization.She will need a bone increased offset implant.I will see her back as needed.".

Manufacturer Narrative

The lot met the specifications for release.This report was originally filed on 03feb2017 on the test server.The account was approved and moved to the production server on 7august2017.I was informed to resubmit all previous files to the production server.Production account approval help desk ticket # (b)(4).Notification of moving files to production account help desk ticket # (b)(4).

Event Description

Event description as received on (b)(6) 2016: "faxed paper work from the pap group stating it started on the right side first injected 2cc of orthovisc batch number n150087a, 01/18 expiration with 2cc of 1% lidocaine without epinephrine or preservative and 40 mg of preservative free kenalog.I prepped with alcohol and chloraprep.I injected without difficulty.I did get verbal consent and the patient identified the right side as the correct side.I then went to the left side third injection 2cc of orthovisc batch number n150087a, 01/18 expiration and with 2cc of 1% lidocaine without epinephrine or preservatives and 40 mg of preservative free kenalog.I prepped with alcohol and chloraprep.I injected with following ethyl chloride anesthesia into the glenohumeral joint without difficulty.This is the third injection in her left shoulder so we did two injections one in the right one in the left both third injections.She tolerated the injections sent her on the way talked about surgery.She did fall.She got x-rays at (b)(6) two views right shoulder.She has pretty severe medialization multiple vascular clips consisting with lymph node dissection and a small chip medially inferior glenoid.I do believe that her humorous is impinging on her glenoid inferiorly because she has a medial wear and probably cracked that.Otherwise, i did not see any fracture that were obvious my thoughts even doing a shoulder replacement on her.It is going to be a challenge because she has such medialization.She will need a bone increased offset implant.I will see her back as needed.".

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: armando botelho ; 32 wiggins ave; bedford, MA 01730 ; 7814579000
• MDR Report Key: 6786460
• MDR Text Key: 82466570
• Report Number: 3007093114-2017-00002
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: (01)10886705023110
• Combination Product (y/n): N
• PMA/PMN Number: 090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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: N/A
• Device Lot Number: N150087A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR