MAUDE Adverse Event Report: BIOMET, INC. RINGLOC; PROSTHESIS, HIP, SEMI-CONSTRAINED

Model Number 31-434540

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

An acetabular cup was loaded on threaded tip of biomet cup inserter.A mallet was used at the distal end to impact the acetabular cup into place in the patient's joint.After removal of the cup inserter instrument, the surgeon noted two small metallic pieces from the threads of the cup inserter were lying in the patient's soft tissue.An additional cup inserter was obtained and the visible metallic pieces were removed from the wound.An x-ray was taken at the end of the procedure to verify that there were no remaining pieces left in wound.
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manufacturer response for biomet mallory cup inserter instrument used during total hip surgery, biomet mallory cup inserter (per site reporter).
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picked up by vendor for investigation.

• Brand Name: RINGLOC
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): BIOMET, INC.; 56 east bell drive; p.o box 587; warsaw IN 46581
• MDR Report Key: 4797899
• MDR Text Key: 5820622
• Report Number: 4797899
• Device Sequence Number: 1
• Product Code: MEH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 31-434540
• Device Lot Number: 155540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR