MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANTS - RIGIDFIX; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK - IMPLANTS - RIGIDFIX

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: lopez, g., et al (2008), anterior cruciate ligament revision with achilles freeze-dried allografts (p15-1023), knee surgery sports traumatology arthroscopy vol.16 (suppl.1), pages s80-s230 (spain).The study emphasizes on analyzing the long-term results of acl revision with freeze-dried allografts.The patients evaluated on course of this study: between january 1999 and december 2005, a total of 55 patients, with an average age of 29 years (range 19-51 years), who had previously failed an acl reconstruction were included in the study.Thirty-five patients had an associated meniscal injury, 30 underwent partial meniscectomy and 5 collagen meniscal implant.Radiographs and mris were performed at 6, 12 and 18 months postoperatively.The article describes the following procedure: a revision of anterior cruciate ligament with achilles freeze-dried allografts.The device involved was: rigidfix.Complications mentioned in the article: 20 patients (36%) had referred knee instability.- 10 patients required acl revision with fresh-frozen allografts.The histology of the failed freeze-dried allograft showed degenerative changes with poorly organized collagen fibers.2 patients developed septic arthritis.41% of the patients had persistent postoperative knee effusion.

• Brand Name: UNK - IMPLANTS - RIGIDFIX
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9295491
• MDR Text Key: 185252973
• Report Number: 1221934-2019-59449
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANTS - RIGIDFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention