MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNK HIP; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 11/14/2007

Event Type  Injury  

Event Description

It was reported that patient enrolled in a clinical study underwent right total hip arthroplasty on an unknown date in 1981.Subsequently, patient underwent a revision procedure on an unknown date in 1987 for unknown reasons.It was further reported patient underwent a radical debridement procedure on (b)(6) 1996 for unknown reasons.Subsequently, patient was revised on the right side on (b)(6) 2007 due to subluxation, dissociation of the modular head from the femoral stem, osteolysis and loosening of the cup.The modular head, acetabular cup and liner were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-00606 / 02986).

Event Description

Biomet orthopedics received preliminary clinical data regarding patients enrolled in a clinical study.It was reported that patient underwent right total hip arthroplasty on an unknown date.Subsequently, patient was revised on the right side on (b)(6) 2007, due to dissociation of the modular head from the femoral stem.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.The following sections could not be completed with the limited information provided: product identification/expiry date.Date implanted.Manufacture date.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 2 mdr's filed for the same event (reference 1825034-2014-00606 / 02986).

• Brand Name: UNK HIP
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3601646
• MDR Text Key: 4552013
• Report Number: 0001825034-2014-00606
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2014

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 01/31/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/17/2014; 05/01/2014
• 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 Age: 80 YR
• Patient Weight: 78