MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SIZE 9 M/L TAPER STEM; PROSTHETIC, HIP

Model Number N/A

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

Patient Problems Bacterial Infection (1735); Hematoma (1884); Pain (1994); Impaired Healing (2378); Post Operative Wound Infection (2446); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 10/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 reviewed and found to be conforming with no applicable deviations, further eliminating the implanted devices as a potential source for the reported infection.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.As device has not been indicated as revised and there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Of note, the identified infectious organisms staph epidermidis bacteria is a common and normally harmless colonizing bacteria of healthy skin flora and mucous membranes.Staph epidermidis is an opportunistic and a prevalent cause of nosocomial (healthcare / facility acquired) infections.The patient was treated, and the devices remained implanted.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression 'wound concerns' or 'non-healing wound' would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.It is noted an i&d (incision & debridement) was performed on the superficial non-healing wound.An i&d procedure can be used to promote the healing process, and this is a common procedure used to treat a non-healing incision site.This deviation signifies an alteration in the wound healing process.The patient has noted comorbidities of diabetes, hyperlipidemia, and obesity that would also contribute to altered/delayed wound healing.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -02130, 0001822565 -2021 -02127, 0001822565 -2021 -02129.

Event Description

It was reported patient underwent a initial left tha, subsequently was revised 8 years later and had i&d down to bone, re-repair of left hip partial abductors due to pain, low grade fever, drainage from incision and infection.No debridement of joint or exchange of components, started on iv antibiotics with home care services.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN SIZE 9 M/L TAPER STEM
• Type of Device: PROSTHETIC, 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: 12252020
• MDR Text Key: 264279612
• Report Number: 0001822565-2021-02128
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2021

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
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 07/30/2021
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 109