MAUDE Adverse Event Report: ETEX CORPORATION CMPL F&A 3CC END 15GAX60MM; PROSTHESIS, BIOLOGICS, BONE SUBSTITUTE MATERIAL

Catalog Number 514.315

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported by patient's legal counsel that the patient claims to have sprained their ankle approximately three (3) years and four (4) months ago.Subsequently, patient received a series of three (3) steroid injections after the sprain occurred.Approximately two (2) months later, the patient underwent a left ankle surgical procedure which included the injection of accufill bsm.Legal claim states patient's ankle did not improve after the procedure and continues to suffer from pain, ambulatory issues, and possible leg amputation.Patient is currently using an exosym brace as well as either crutches or a wheelchair since the implantation.No revision has been reported at this time.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.A review of the documents noted the following - the patient fell on steps and sprained her left ankle.She was treated with steroid injections which did not resolve her pain.On (b)(6) 2017, she underwent an injection of accufill bsm into the left talar neck and head.Subsequently, it was reported the patient experienced avascular necrosis and may be considered for below-the-knee amputation.Her adls have since been limited, she now uses mobility aides and has ongoing pain.The document further reports that the patient was not a candidate for an accufill injection.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.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.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: 3008812173-2022-00001.

Event Description

No further event information available at the time of this report.

• Brand Name: CMPL F&A 3CC END 15GAX60MM
• Type of Device: PROSTHESIS, BIOLOGICS, BONE SUBSTITUTE MATERIAL
• Manufacturer (Section D): ETEX CORPORATION; 38 sidney street; third floor; cambridge MA 02139
• Manufacturer (Section G): ETEX CORPORATION; 38 sidney street; third floor; cambridge MA 02139
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11015902
• MDR Text Key: 221750938
• Report Number: 0001225112-2020-00005
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 514.315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Hispanic