MAUDE Adverse Event Report: BIOMET BIOLOGICS GPS III SINGLE KIT W/30ML ACDA; SUPPLIES, BLOOD-BANK

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 01/20/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.(b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states, "early or late postoperative infection.".

Event Description

Legal counsel for the patient reported that the patient underwent a drainage procedure approximately 18 days after an arthroscopic surgical procedure in which biological material was utilized due to infection, pain, abscess formation, wound drainage, erythema, and redness and swelling of the left shoulder.Legal counsel additionally alleges that the patient's rotator cuff was noted to be friable upon examination during the drainage procedure.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of sterilization certification confirms device was sterilized in accordance with (b)(4).

Manufacturer Narrative

This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.Concomitant medical product - mixing applicator tip, catalog#: 800-0252, lot#:129422; biomet biologics spray kit.Catalog#: 800-0250, lot#: 132592.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: n/a, device is a solution and not an explantable device reported event was confirmed by review of provided medical record documentation.No medical records received; however, notes were provided with the legal paperwork which include a review of medical records.At 5 days post op, the patient complained of pain and presented to the emergency room.Medication was given to manage the pain.At 7 days post op, the patient presented to the surgeon's office and was prescribed additional pain medication.At 10 days post op, the patient presented to the emergency room due to pain and fever.A ct examination was performed and found enhanced fluid collection that is consistent with wound infection, suspicious for abscess.The records indicate that the surgeon ordered no antibiotics be administered at this that time.At 11 days post op, the patient was seen by a second physician and the patient was discharged.At 12 days post op, the surgeon prescribed oral antibiotics due to complaints of pain, fever, and drainage from the surgical site.At 13 days post op, patient was seen by the initial surgeon who noted purulent tissue and chose to continue oral antibiotics.At 16 days post op, surgeon was again contacted due to complaints of wound draining puss.At 18 days post op, the wound was drained.Purulent material was drained and the tissue of the joint was found to be friable and non-viable rotator cuff tissue broke apart during the procedure.At 112 days post op, the patient was revised due to the failed arthroscopic surgery.Device history record (dhr) was reviewed and no discrepancies were found.Further review of reported product found it related to a supplier recall performed in 2016.A definitive root cause could not be determined, as it cannot be confirmed the recalled product caused or contributed to the reported event.Corrective actions were initiated for the recalled devices.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.

Manufacturer Narrative

(b)(4).Implant and explant dates should be left blank as it was determined that this complaint product should not be marked as an implant.

• Brand Name: GPS III SINGLE KIT W/30ML ACDA
• Type of Device: SUPPLIES, BLOOD-BANK
• Manufacturer (Section D): BIOMET BIOLOGICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6137143
• MDR Text Key: 61186669
• Report Number: 0001825034-2016-04955
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PBK070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 800-1003A
• Device Lot Number: 402274
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: B-0729-16, B-0730-16
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention