MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 07/01/1994

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant products: item #unk, unknown head, lot #unk; item #unk, unknown cup, lot #unk; item #unk, unknown liner, lot #unk; item #unk, unknown stem, lot #unk.Huk, o.L., bansal, m., betts, f., rimnac, c.M., lieberman, j.R., huo, m.H., & salvati, e.A.(1994).Polyethylene and metal debris generated by non-articulating surfaces of modular acetabular components.The journal of bone and joint surgery, 76 b(4), 568-574.Retrieved from http://bjj.Boneandjoint.Org.Uk/content/jbjsbr/76-b/4/568.Full.Pdf.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported in a journal articlet that metal particles were present in five specimens at an average grade of 1, and were much smaller (0.1 to 5 u.M in diameter).No further information is available.

• Brand Name: UNKNOWN SCREW
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6732008
• MDR Text Key: 80674199
• Report Number: 0001825034-2017-05138
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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