MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RAN/BUR RNGLC SHL 56MM SZ 24; PROSTHESIS, HIP

Model Number N/A

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 05/11/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial total hip arthroplasty on an unknown date.Subsequently, patient was revised on (b)(6) 2015 due to unknown reasons.During the revision procedure, the surgeon attempted to remove the modular head, but it would not come off and had to be left in place.The acetabular cup and liner were removed and replaced with competitor products.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.The root cause of the event is unconfirmed.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent initial total hip arthroplasty in 1998.Subsequently, patient was revised on (b)(6) 2015 due to unknown reasons.During the revision procedure, the surgeon attempted to remove the modular head, but it would not come off and had to be left in place.The acetabular cup and liner were removed and replaced with competitor products.

• Brand Name: RAN/BUR RNGLC SHL 56MM SZ 24
• 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: 4827094
• MDR Text Key: 5836624
• Report Number: 0001825034-2015-02490
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050124
• 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,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2008
• Device Model Number: N/A
• Device Catalogue Number: 106056
• Device Lot Number: 421460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/1998
• 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