MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TPRLC 133 MP TYPE1 PPS HO 11.0; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Failure to Disconnect (2541)

Patient Problem Unspecified Infection (1930)

Event Date 07/02/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015.Subsequently, a revision procedure was performed on (b)(6) 2015 due to periprosthetic joint infection.During the procedure, the modular head would not disengage from the femoral stem and the stem loosened from the femoral canal.The femoral stem, modular head and liner were removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: "early or late postoperative infection and/or allergic reaction." device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2015-03464 - 03466).

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Evaluation could not confirm the complaint.A visual review of the stem showed no evidence of bony ingrowths.

• Brand Name: TPRLC 133 MP TYPE1 PPS HO 11.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4965799
• MDR Text Key: 6193298
• Report Number: 0001825034-2015-03466
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 51-107110
• Device Lot Number: 3545237
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 08/04/2015
• 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: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 127