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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source: (b)(6).Concomitant medical devices: catalog number:11-300816 lot number: 796550 brand name: arcos 16x150mm spl tpr dist; catalog number:22-301112 lot number:013410 brand name: arcos brch sz b hi 60mm ha; unknown liner; unknown cup.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02091, 0001825034-2020-02092, 0001825034-2020-02094, 0001825034-2020-02095.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.

Event Description

It was reported that the patient is being indicated for a revision due to unknown reasons with suspected infection.However, a revision has not been reported.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 the reported device did not cause or contribute to the event.

Event Description

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

• Brand Name: UNKNOWN HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10080648
• MDR Text Key: 194310490
• Report Number: 0001825034-2020-02093
• Device Sequence Number: 1
• Product Code: LZO
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/I
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other