MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD -3MM NK; PROSTHETIC, HIP

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling/ Edema (4577)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4).D10: 110010262 item name g7 osseoti multihole 48mm c lot # unknown.110024461 item name g7 dual mobility liner 38mm c lot # unknown.22-301323 arcos con sz c std 70mm ha lot # unknown.22-300916 item name arcos 16x190mm spl tpr dist ha lot # unknown.G2: foreign: spain.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02249 0001825034 - 2023 - 02250 0001825034 - 2023 - 02252 0001825034 - 2023 - 02253 the device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device remains implanted.

Event Description

It was reported that 11 days post implantation, the patient presented with worsening pain.The patient had swelling in the proximal region of the intervened limb.The joint was drained three times during the patient's admission.The implants remain implanted.There is no additional information available at the time of this report.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery.This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Superficial infections are considered a procedure related complication as no device has been reported as revised.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.During the investigation process a review of the sterile certifications were not reviewed, as no product part/lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.A superficial infection was reported and no product information was provided; therefore, validation of sterile certifications cannot be performed.However, the reported event is considered procedure related.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 28MM DIA COCR MOD HD -3MM NK
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17821171
• MDR Text Key: 324301689
• Report Number: 0001825034-2023-02251
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K942479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 163661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2023
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 78 KG