MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; PROSTHESIS, HIP

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Fall (1848); Osteolysis (2377)

Event Date 06/18/2020

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 has not been returned by hospital.The investigation is in process.Once the investigation is complete, a follow¿up mdr will be submitted.Concomitant medical products: item#: unknown, unknown head, lot #: unknown.Item#: unknown, unknown cup, lot #: unknown.Item#: unknown, unknown liner, lot #: unknown.Item#: unknown, unknown stem, lot #: unknown.Item#: unknown, unknown screw, lot #: unknown, quantity 5.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -02678, 0001825034 ¿2020 -02679, 0001825034 -2020 -02681, 0001825034 -2020 -02682, 0001825034 -2020 -02683, 0001825034 -2020 -02684.

Event Description

It was reported patient underwent hip revision surgery approximately one month ago due to a fall that caused loosening to cup and screws to fracture.Cup and head were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

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

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.

• Brand Name: UNKNOWN SCREW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10258041
• MDR Text Key: 198675246
• Report Number: 0001825034-2020-02685
• Device Sequence Number: 1
• Product Code: KWA
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention