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 Problems Wound Dehiscence (1154); Swelling (2091); Impaired Healing (2378)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign country: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04981, 0001822565 - 2019 - 05095, 0001822565 - 2019 - 05096.

Event Description

It was reported the patient underwent a full artificial joint replacement and the wound showed repeated symptoms of redness, swelling, rupture and exudation after the operation.Approximately 9 days later, the patient underwent a dilated and invasive catheter drainage, and the wound healed upon discharge.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• 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: 9386155
• MDR Text Key: 168447060
• Report Number: 0001822565-2019-05097
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET SCREW 6.5X20MM CAT# 103531 LOT# 547580; BIOMET SCREW 6.5X20MM CAT# 103531 LOT# 547720; UNKNOWN LINER; UNKNOWN STEM; ZIMMER CUP CAT#00875305001 LOT#63861501
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR