MAUDE Adverse Event Report: BIOMET, INC. RING LOC; PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL

Catalog Number B STD 989820 & 38X58 MM 93965

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

Male patient had surgery several years ago for total hip arthroplasty and has had pain w/hip flexion and had revision on approximately one year ago.The head was removed from the stem.The patient was found to have mild fretting and mild corrosion on both the head and the stem morse taper.

• Brand Name: RING LOC
• Type of Device: PROSTHESIS, HIP, HEMI-, ACETABULAR, CEMENTED, METAL
• Manufacturer (Section D): BIOMET, INC.; 56 east bell drive; po box 587; warsaw IN 46581
• MDR Report Key: 5177084
• MDR Text Key: 29238930
• Report Number: 5177084
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: B STD 989820 & 38X58 MM 93965
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2015
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 95