MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.5 MM FEMALE HEX SCREW 25 MM LENGTH; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: 42512200510, articular surface fixed bearing, lot # 63880311; 42532007101, natural tibia, lot # 63895745; 42540000029, all poly patella, lot # 63890774; 42502606401, femur, lot # 63590448; 00590103533, 3.5 mm hex head screw, lot # 63963443; 42509902525, 2.5 mm hex screw, lot # 64038534, quantity x2.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00278, 3007963827-2019-00279, 0002648920-2019-00714, 3007963827-2019-00279, 0001822565-2019-04191, 0001822565-2019-04192.

Event Description

It was reported that approximately 1 year post implantation, the patient has been experiencing pain, loss of mobility, and device loosening.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

No further event information available at the time of this report.

• Brand Name: 2.5 MM FEMALE HEX SCREW 25 MM LENGTH
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9128876
• MDR Text Key: 162464546
• Report Number: 0001822565-2019-04193
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42509902525
• Device Lot Number: 64038534
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other