MAUDE Adverse Event Report: BIOMET REGENEREX RINGLOC; PROSTHESIS, HIP

Catalog Number EP-108223

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 04/03/2015

Event Type  malfunction  

• Brand Name: REGENEREX RINGLOC
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET; 56 east bell drive; p.o. box 587; warsaw IN 46581
• MDR Report Key: 4732560
• Report Number: 4732560
• Device Sequence Number: 1
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: EP-108223
• Device Lot Number: 165060
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2015
• Patient Sequence Number: 1
• Patient Age: 73 YR