MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK 36+10.5 FEMORAL HEAD; PROSTHESIS, HIP

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

Patient Problems Bacterial Infection (1735); Hematoma (1884); Impaired Healing (2378)

Event Date 08/07/2019

Event Type  Injury  

Event Description

It was reported that patient underwent total left hip arthroplasty approximately 4 years ago.Subsequently, the patient underwent two separate revisions of the acetabular and femoral components due to loosening.Approximately three weeks after the second revision, the patient experienced a postop hematoma which was surgically debrided without complication.Intraop cultures grew staphylococcus epidermis indicating a superficial infection.The debridement did not extend into the joint, and no product was exchanged.After changing the postop antibiotics, the patient healed without further complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # unknown / unk tm 64mm cup/ lot # unknown; part #unknown / unk liner/ lot # unknown; part #unknown / unk screws/ lot # unknown/ quantity 7.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2022 -00226, 0001822565 -2022 -00229, 0001822565 -2022 -00230.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

• Brand Name: UNK 36+10.5 FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13391598
• MDR Text Key: 284721487
• Report Number: 0001822565-2022-00225
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 114 KG