MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM 28MM RNGLOC LNR 10DEG24; PROSTHESIS, HIP

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Naturally Worn (2988)

Patient Problems Pain (1994); Osteolysis (2377)

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 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: under possible adverse effects, number 1 states, "material sensitivity reactions." this report is number 4 of 5 mdrs filed for the same event (reference 0001825034-2016-02612 / 02616).Remains implanted.

Event Description

Patient has indicated the potential need for a left hip revision due to osteolysis.

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 4 of 16 mdrs filed for the same patient (reference 0001825034-2016-02612 / 02616 and 02932 / 02934 and 02937 / 02944).

Event Description

Patient has indicated the potential need for a left hip revision due to osteolysis, elevated metal ion levels and suspected loosening of the acetabular component.This report is based on allegations set forth in patient'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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 11 states, ¿wear and/or deformation of articulating surfaces.¿ number 14 states, "postoperative bone fracture and pain." this report is number 4 of 20 mdrs filed for the same event (reference 0001825034-2016-02612 / 02616 & 02932 / 02934 & 02937 / 02944 & 03405 / 03408).

Event Description

Patient has indicated the potential need for a left hip revision due to osteolysis, elevated metal ion levels and suspected loosening of the acetabular component.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.It was reported in medical records received that patient experiences osteolysis, pain and particulate wear of the liner.

• Brand Name: ARCOM 28MM RNGLOC LNR 10DEG24
• 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: 5799955
• MDR Text Key: 49736291
• Report Number: 0001825034-2016-02615
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK926107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2007
• Device Model Number: N/A
• Device Catalogue Number: 11-105914
• Device Lot Number: 026910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2002
• 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): Required Intervention