MAUDE Adverse Event Report: ENCORE MEDICAL L.P. UKNOWN; UNKNOWN

Catalog Number 114700

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

Part discarded; part left in patient.

Event Description

Revision surgery - the patient had not been adhering to the weight lifting restrictions, so the polyethylene bearing wore down causing revision.

Manufacturer Narrative

Corrected data: part number 114700, lot 954590 was reported as the suspect medical device on the initial medial device report it should be the concomitant part.The main suspect medical device is unknown.Manufacturer narrative: the reason for this revision surgery was the polyethylene bearing wore down.The actual length of in-vivo patient service for this product is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.It was reported that part of the device was disposed of and part was left int the patient, it was not made available to djo surgical for examination.A review of the device history record (dhr) was not conducted since a lot number and part number was not provided or determined during the complaint evaluation.A search of the device investigation produced no anomalies or evidence of a product issue.The implant in-vivo service length is unknown without an original surgery date.Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event.Zimmer-biomet was contacted for additional information through an invoice search and reported they have no additional information to report for this evaluation.This complaint will be closed with the main part number and lot number unknown pending receipt of additional information.Should additional information become available concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint is deemed to be non-product related.The complaint states the patient had not been adhering to the weight lifting restrictions, so polyethylene bearing wore down.No other conditions relating to this event could be determined with confidence.The surgeon reported no issues associated with the explanted product.

• Brand Name: UKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 6227323
• MDR Text Key: 64014285
• Report Number: 1644408-2016-01041
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 0888912224833
• UDI-Public: (01)0888912224833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114700
• Device Lot Number: 954590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR