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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN SIZE 9 M/L TAPER STEM PROSTHETIC, HIP Back to Search Results
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.
 
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Brand NameUNKNOWN SIZE 9 M/L TAPER STEM
Type of DevicePROSTHETIC, 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 Key12252020
MDR Text Key264279612
Report Number0001822565-2021-02128
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/12/2021
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 NumberN/A

Patient Treatment Data
Date Received: 07/30/2021 Patient Sequence Number: 1
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